Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2026-02-03 @ 12:07 AM
Study NCT ID:
NCT02142361
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2014-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance of Habitual Hydrogel vs. Silicone Hydrogel Toric Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robert.montes@uv.es', 'phone': '34-9635-44764', 'title': 'Robert Montés-Mico O.D., MPhil, PhD Optometry', 'organization': 'Optometry Research Group (GIO)'}, 'certainAgreement': {'otherDetails': "Principal Investigators are NOT employed by the organization sponsoring the study.\n\nThere IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.\n\nThe investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Dispense up to one week for each study lenses', 'eventGroups': [{'id': 'EG000', 'title': 'Omafilcon A', 'description': "Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.\n\nenfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.", 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ocufilcon D', 'description': "Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.\n\nenfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.", 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Methafilcon B', 'description': "Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.\n\nenfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.", 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Lens Initial Comfort", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Omafilcon A', 'description': "Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': "Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG002', 'title': 'Methafilcon B', 'description': "Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}], 'classes': [{'title': 'Habitual lens-Baseline', 'categories': [{'measurements': [{'value': '6.9', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '8.0', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Study lens-1 Week', 'categories': [{'measurements': [{'value': '8.9', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '1.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': "Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Lens Comfort Prior to Removal", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Omafilcon A', 'description': "Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': "Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG002', 'title': 'Methafilcon B', 'description': "Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}], 'classes': [{'title': 'Habitual lens -Baseline', 'categories': [{'measurements': [{'value': '7.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '6.7', 'spread': '2.0', 'groupId': 'OG002'}]}]}, {'title': 'Study Lens -1 week', 'categories': [{'measurements': [{'value': '8.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '2.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': "Surveyed prior to removal of each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Overall Lens Comfort", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Omafilcon A', 'description': "Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': "Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG002', 'title': 'Methafilcon B', 'description': "Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}], 'classes': [{'title': 'Habitual lens- Baseline', 'categories': [{'measurements': [{'value': '8.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Study lens-1 week', 'categories': [{'measurements': [{'value': '8.8', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '1.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': "Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Dryness During the Day", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Omafilcon A', 'description': "Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': "Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG002', 'title': 'Methafilcon B', 'description': "Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}], 'classes': [{'title': 'Habitual lens-Baseline', 'categories': [{'measurements': [{'value': '7.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '7.4', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Study lens-1 week', 'categories': [{'measurements': [{'value': '8.6', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '1.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Dryness Prior to Removal", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Omafilcon A', 'description': "Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': "Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG002', 'title': 'Methafilcon B', 'description': "Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}], 'classes': [{'title': 'Habitual lens-Baseline', 'categories': [{'measurements': [{'value': '7.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '2.2', 'groupId': 'OG002'}]}]}, {'title': 'Study lens-1 week', 'categories': [{'measurements': [{'value': '7.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '7.5', 'spread': '2.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed prior to removal of each lens pair. Habitual pair at baseline . Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Overall Dryness", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Omafilcon A', 'description': "Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': "Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG002', 'title': 'Methafilcon B', 'description': "Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}], 'classes': [{'title': 'Habitual lens-Baseline', 'categories': [{'measurements': [{'value': '7.8', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '7.2', 'spread': '1.9', 'groupId': 'OG002'}]}]}, {'title': 'Study lens-1 week', 'categories': [{'measurements': [{'value': '8.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '1.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Lens Handling - Insertion", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Omafilcon A', 'description': "Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': "Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG002', 'title': 'Methafilcon B', 'description': "Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}], 'classes': [{'title': 'Habitual lens-Baseline', 'categories': [{'measurements': [{'value': '8.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '9.1', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Study lens-1 week', 'categories': [{'measurements': [{'value': '9.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '9.5', 'spread': '0.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= very easy)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Overall Lens Fit Stability", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Omafilcon A', 'description': "Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': "Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG002', 'title': 'Methafilcon B', 'description': "Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}], 'classes': [{'title': 'Habitual lens-Baseline', 'categories': [{'measurements': [{'value': '8.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '7.9', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Study Lens- 1 week', 'categories': [{'measurements': [{'value': '8.1', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '9.0', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very unstable / excessive movement, 10= very stable / good movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Overall Vision Satisfaction", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Omafilcon A', 'description': "Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': "Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG002', 'title': 'Methafilcon B', 'description': "Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}], 'classes': [{'title': 'Habitual lens- Baseline', 'categories': [{'measurements': [{'value': '8.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '8.6', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Study lens-1 week', 'categories': [{'measurements': [{'value': '8.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '9.3', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=completely dissatisfied, 10= very satisfied)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Vision Quality at Insertion", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Omafilcon A', 'description': "Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': "Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG002', 'title': 'Methafilcon B', 'description': "Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}], 'classes': [{'title': 'Habitual lens-Baseline', 'categories': [{'measurements': [{'value': '77', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '75.5', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '79.5', 'spread': '10.0', 'groupId': 'OG002'}]}]}, {'title': 'Study lens-1 week', 'categories': [{'measurements': [{'value': '87.5', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '82.5', 'spread': '12.5', 'groupId': 'OG001'}, {'value': '86.5', 'spread': '9.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week .Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Vision Quality During the Day", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Omafilcon A', 'description': "Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': "Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG002', 'title': 'Methafilcon B', 'description': "Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}], 'classes': [{'title': 'Habitual lens-Baseline', 'categories': [{'measurements': [{'value': '83', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '86', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '84.5', 'spread': '11.9', 'groupId': 'OG002'}]}]}, {'title': 'Study lens-1 week', 'categories': [{'measurements': [{'value': '87.5', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '85', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '91.5', 'spread': '7.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Vision Quality End of the Day", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Omafilcon A', 'description': "Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': "Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG002', 'title': 'Methafilcon B', 'description': "Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}], 'classes': [{'title': 'Habitual lens-Baseline', 'categories': [{'measurements': [{'value': '79', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '82.5', 'spread': '14.1', 'groupId': 'OG001'}, {'value': '76', 'spread': '14.1', 'groupId': 'OG002'}]}]}, {'title': 'Study lens-1 week', 'categories': [{'measurements': [{'value': '79.8', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '80.5', 'spread': '13.9', 'groupId': 'OG001'}, {'value': '87.5', 'spread': '9.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week end of the day. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Night Vision Quality", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Omafilcon A', 'description': "Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': "Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG002', 'title': 'Methafilcon B', 'description': "Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}], 'classes': [{'title': 'Habitual lens-Baseline', 'categories': [{'measurements': [{'value': '77.3', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '83.3', 'spread': '10.5', 'groupId': 'OG001'}, {'value': '81.8', 'spread': '10.0', 'groupId': 'OG002'}]}]}, {'title': 'Study lens-1 week', 'categories': [{'measurements': [{'value': '83.5', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '84.5', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '87.3', 'spread': '8.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Study pair dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Vision Stability at Insertion", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Omafilcon A', 'description': "Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': "Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG002', 'title': 'Methafilcon B', 'description': "Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}], 'classes': [{'title': 'Habitual lenses-Baseline', 'categories': [{'measurements': [{'value': '74', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '70', 'spread': '12.6', 'groupId': 'OG001'}, {'value': '71.5', 'spread': '15.3', 'groupId': 'OG002'}]}]}, {'title': 'Study lens-1 week', 'categories': [{'measurements': [{'value': '86.5', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '81', 'spread': '14.1', 'groupId': 'OG001'}, {'value': '85.5', 'spread': '10.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Vision Stability During the Day", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Omafilcon A', 'description': "Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': "Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG002', 'title': 'Methafilcon B', 'description': "Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}], 'classes': [{'title': 'Habitual lens-Baseline', 'categories': [{'measurements': [{'value': '83', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '81.5', 'spread': '10.9', 'groupId': 'OG001'}, {'value': '77.5', 'spread': '16.2', 'groupId': 'OG002'}]}]}, {'title': 'Study lens-1 week', 'categories': [{'measurements': [{'value': '82.5', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '82.5', 'spread': '12.1', 'groupId': 'OG001'}, {'value': '90', 'spread': '7.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Vision Stability at End of Day", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Omafilcon A', 'description': "Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': "Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'OG002', 'title': 'Methafilcon B', 'description': "Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}], 'classes': [{'title': 'Habitual lens-Baseline', 'categories': [{'measurements': [{'value': '81', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '79.5', 'spread': '13.9', 'groupId': 'OG001'}, {'value': '75.5', 'spread': '16.4', 'groupId': 'OG002'}]}]}, {'title': 'Study lens-1 week', 'categories': [{'measurements': [{'value': '77.5', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '82', 'spread': '13.2', 'groupId': 'OG001'}, {'value': '88.5', 'spread': '7.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Lens Pair Preference", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at 1 week.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'Overall', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Comfort', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Dryness', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Handling', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'Vision', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Lens Fit', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Participants subjective preference in relation to comfort, dryness, handling, vision, lens fit and overall of the patient after wearing the study and their habitual lenses.', 'unitOfMeasure': 'Percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'All 60 paticipants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. "Vision" category data for one participant was not collected.'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Overall Satisfaction - Dryness", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'completely satisfied', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'somewhat satisfied', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'somewhat dissatisfied', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'completely dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Overall Satisfaction - Handling", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'completely satisfied', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'somewhat satisfied', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'somewhat dissatisfied', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'completely dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.\n\nSum of percentage for the Study Lens Arm=101 as, Category title- " Somewhat dissatisfied- 1.7 was rounded to 2.'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Overall Satisfaction - Vision", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'completely satisfied', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'somewhat satisfied', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'somewhat dissatisfied', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'completely dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Overall Satisfaction - Lens Fit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'completely satisfied', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'somewhat satisfied', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'somewhat dissatisfied', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'completely dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Overall Satisfaction - Overall", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'completely satisfied', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'somewhat satisfied', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'somewhat dissatisfied', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'completely dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': "Clinician's Objective Assessment Monocular High Contrast Distance Visual", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'VA Oculus Dexter (OD)', 'categories': [{'measurements': [{'value': '-0.037', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '-0.037', 'spread': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'VA Oculus Sinister (OS)', 'categories': [{'measurements': [{'value': '-0.037', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '-0.037', 'spread': '0.049', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value.', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': "Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.037', 'spread': '0.0049', 'groupId': 'OG000'}, {'value': '-0.037', 'spread': '0.0049', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': "Clinician's Assessment Overall Lens Stability-Right Eye", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'Very Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Excellent', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': "Clinician's Assessment Overall Lens Stability-Left Eye", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'Very Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Excellent', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. 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Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': "Clinician's Assessment Lens Centration-Right Eye", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'Centered', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Slightly decentered', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Substantially decentered', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. 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The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': "Clinician's Assessment Lens Centration- Left Eye", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'Centered', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Slightly decentered', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Substantially decentered', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Lens centration recorded by degree and direction in the primary positions. (0-2, 0=centered/optimal, 1=decentered slightlty, 2=substantially decentered (\\>0.5mm)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': "Clinician's Assessment Corneal Coverage-Right Eye", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'Full corneal coverage', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Incomplete corneal coverage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no, incomplete corneal coverage)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': 'Clinicians Assessment Corneal Coverage-Left Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'Full corneal coverage', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Incomplete corneal coverage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no incomplete corneal coverage)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': "Clinician's Assessment Post-Blink Movement- Right Eye", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'Insufficient/Unacceptable movement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Minimal, but acceptable movement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Optimal movement,', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Moderate, but acceptable movement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Excessive, inacceptable movement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': "Clinician's Assessment Post-Blink Movement-Left Eye", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'Insufficient/Unacceptable movement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Minimal, but acceptable movement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Optimal movement', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Moderate, but acceptable movement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Excessive,unacceptable movement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': "Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'Temporal', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '0 rotation', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Nasal', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': "Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.", 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': "Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'Temporal', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '0 rotation', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Nasal', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': "Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.", 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': "Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': "Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Overall Satisfaction - Comfort", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lenses', 'description': 'Subjects habitual hydrogel toric lens pairs surveyed at baseline.'}, {'id': 'OG001', 'title': 'Study Lens', 'description': 'Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.'}], 'classes': [{'title': 'Completely satisfied', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'somewhat satisfied', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'somewhat dissatisfied', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'completely dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omafilcon A/Enfilcon A', 'description': "Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'FG001', 'title': 'Ocufilcon D/Enfilcon A', 'description': "Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}, {'id': 'FG002', 'title': 'Methafilcon B/Enfilcon A', 'description': "Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study Group', 'description': 'All participants were habitual wearers of hydrogel toric lenses (omafilcon A, ocufilcon D or methafilcon B), and refitted with silicone hydrogel toric lens (enfilcon A)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '5.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The subject sample consisted of 60 habitual hydrogelcontact lens wearers (omafilcon A, ocufilcon D or methafilcon B), refitted with silicone hydrogel lens (enfilcon A)'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-19', 'studyFirstSubmitDate': '2014-05-16', 'resultsFirstSubmitDate': '2016-02-23', 'studyFirstSubmitQcDate': '2014-05-19', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-04-14', 'studyFirstPostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Participant's Subjective Rating for Lens Initial Comfort", 'timeFrame': 'Baseline and 1 week', 'description': "Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)"}, {'measure': "Participant's Subjective Rating for Lens Comfort Prior to Removal", 'timeFrame': 'Baseline and 1 week', 'description': "Surveyed prior to removal of each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)"}, {'measure': "Participant's Subjective Rating for Overall Lens Comfort", 'timeFrame': 'Baseline and 1 week', 'description': "Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)"}, {'measure': "Participant's Subjective Rating for Dryness During the Day", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)'}, {'measure': "Participant's Subjective Rating for Dryness Prior to Removal", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed prior to removal of each lens pair. Habitual pair at baseline . Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)'}, {'measure': "Participant's Subjective Rating for Overall Dryness", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)'}, {'measure': "Participant's Subjective Rating for Lens Handling - Insertion", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= very easy)'}, {'measure': "Participant's Subjective Rating for Overall Lens Fit Stability", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very unstable / excessive movement, 10= very stable / good movement)'}, {'measure': "Participant's Subjective Rating for Overall Vision Satisfaction", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=completely dissatisfied, 10= very satisfied)'}, {'measure': "Participant's Subjective Rating for Vision Quality at Insertion", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week .Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)'}, {'measure': "Participant's Subjective Rating for Vision Quality During the Day", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)'}, {'measure': "Participant's Subjective Rating for Vision Quality End of the Day", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week end of the day. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)'}, {'measure': "Participant's Subjective Rating for Night Vision Quality", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Study pair dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)'}, {'measure': "Participant's Subjective Rating for Vision Stability at Insertion", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)'}, {'measure': "Participant's Subjective Rating for Vision Stability During the Day", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)'}, {'measure': "Participant's Subjective Rating for Vision Stability at End of Day", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)'}, {'measure': "Participant's Subjective Rating for Lens Pair Preference", 'timeFrame': '1 week', 'description': 'Participants subjective preference in relation to comfort, dryness, handling, vision, lens fit and overall of the patient after wearing the study and their habitual lenses.'}, {'measure': "Participant's Subjective Rating for Overall Satisfaction - Dryness", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)'}, {'measure': "Participant's Subjective Rating for Overall Satisfaction - Handling", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)'}, {'measure': "Participant's Subjective Rating for Overall Satisfaction - Vision", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)'}, {'measure': "Participant's Subjective Rating for Overall Satisfaction - Lens Fit", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)'}, {'measure': "Participant's Subjective Rating for Overall Satisfaction - Overall", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)'}, {'measure': "Clinician's Objective Assessment Monocular High Contrast Distance Visual", 'timeFrame': 'Baseline and 1 week', 'description': 'Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value.'}, {'measure': "Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity", 'timeFrame': 'Baseline and 1 week', 'description': 'Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value'}, {'measure': "Clinician's Assessment Overall Lens Stability-Right Eye", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)'}, {'measure': "Clinician's Assessment Overall Lens Stability-Left Eye", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)'}, {'measure': "Clinician's Assessment Overall Fit Acceptance- Right Eye", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)'}, {'measure': "Clinician's Assessment Overall Fit Acceptance- Left Eye", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)'}, {'measure': "Clinician's Assessment Lens Centration-Right Eye", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Lens centration recorded by degree and direction in the primary position. (0-2, 0=centered/optimal, 1=decentered slightly, 2=substantially decentered (\\>0.5mm))'}, {'measure': "Clinician's Assessment Lens Centration- Left Eye", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Lens centration recorded by degree and direction in the primary positions. (0-2, 0=centered/optimal, 1=decentered slightlty, 2=substantially decentered (\\>0.5mm)'}, {'measure': "Clinician's Assessment Corneal Coverage-Right Eye", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no, incomplete corneal coverage)'}, {'measure': 'Clinicians Assessment Corneal Coverage-Left Eye', 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no incomplete corneal coverage)'}, {'measure': "Clinician's Assessment Post-Blink Movement- Right Eye", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement'}, {'measure': "Clinician's Assessment Post-Blink Movement-Left Eye", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement'}, {'measure': "Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye", 'timeFrame': 'Baseline and 1 week', 'description': "Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees."}, {'measure': "Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye", 'timeFrame': 'Baseline and 1 week', 'description': "Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees."}, {'measure': "Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye", 'timeFrame': 'Baseline and 1 week', 'description': 'Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.'}, {'measure': "Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye", 'timeFrame': 'Baseline and 1 week', 'description': 'Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.'}, {'measure': "Participant's Subjective Rating for Overall Satisfaction - Comfort", 'timeFrame': 'Baseline and 1 week', 'description': 'Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'Evaluate the clinical performance of existing wearers of hydrogel toric lenses when refitted with Avaira toric silicone hydrogel contact lenses over 1 week of wear.', 'detailedDescription': "This is a 60-subject, single masked, bilateral, parallel study design comparing the fitting characteristics of enfilcon A toric lenses against the subjects habitual hydrogel toric lenses (omafilcon A, ocufilcon D or methafilcon B wearers). Subject's habitual toric lenses will be evaluated at the first visit and then re-fitted with a pair of Avaira toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is between 18 and 40 years of age (inclusive)\n* Has had a self-reported visual exam in the last two years\n* Is an adapted soft toric contact lens wearer\n* Has a contact lens spherical prescription between +6.00 to - 8.00 (inclusive)\n* Have no less than 0.75D of astigmatism and no more than 1.75 D in both eyes.\n* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.\n* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.\n* Has clear corneas and no active ocular disease\n* Has read, understood and signed the information consent letter.\n* Patient contact lens refraction should fit within the available parameters of the study lenses.\n* Is willing to comply with the wear schedule (at least 5 days per week, \\> 8 hours/day assuming there are no contraindications for doing so).\n* Is willing to comply with the visit schedule\n\nExclusion Criteria:\n\n* Has a contact lens prescription outside the range of the available parameters of the study lenses.\n* Has a spectacle cylinder less than -0.75D or more than -1.75D of cylinder in either eye.\n* Has a history of not achieving comfortable contact lens wear (5 days per week; \\> 8 hours/day)\n* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.\n* Presence of clinically significant (grade 2-4) anterior segment abnormalities\n* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.\n* Slit lamp findings that would contraindicate contact lens wear such as:\n\n * Pathological dry eye or associated findings\n * Pterygium, pinguecula, or corneal scars within the visual axis\n * Neovascularization \\> 0.75 mm in from of the limbus\n * Giant papillary conjunctivitis (GCP) worse than grade 1\n * Anterior uveitis or iritis (past or present)\n * Seborrheic eczema, Seborrheic conjunctivitis\n * History of corneal ulcers or fungal infections\n * Poor personal hygiene\n* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)\n* Has aphakia, keratoconus or a highly irregular cornea.\n* Has Presbyopia or has dependence on spectacles for near work over the contact lenses.\n* Has undergone corneal refractive surgery.\n* Is participating in any other type of eye related clinical or research study.'}, 'identificationModule': {'nctId': 'NCT02142361', 'briefTitle': 'Clinical Performance of Habitual Hydrogel vs. Silicone Hydrogel Toric Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Clinical Performance of Habitual Wearers of Hydrogel Toric Lenses When Refitted With Avaira Toric Silicone Hydrogel Lenses', 'orgStudyIdInfo': {'id': 'EX-MKTG-48'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Omafilcon A/Enfilcon A', 'description': "Subject's habitual hydrogel toric lenses Omafilcon A will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses.", 'interventionNames': ['Device: enfilcon A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ocufilcon D/Enfilcon A', 'description': "Subject's habitual hydrogel toric lenses Ocufilcon D will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses.", 'interventionNames': ['Device: enfilcon A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methafilcon B/ Enfilcon A', 'description': "Subject's habitual hydrogel toric lenses Methafilcon B will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses.", 'interventionNames': ['Device: enfilcon A']}], 'interventions': [{'name': 'enfilcon A', 'type': 'DEVICE', 'otherNames': ['enfilcon A/Silicone Hydrogel Lens'], 'description': 'Silicone hydrogel toric lenses.', 'armGroupLabels': ['Methafilcon B/ Enfilcon A', 'Ocufilcon D/Enfilcon A', 'Omafilcon A/Enfilcon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46100', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Optometry Research Group (GIO) Optics Department, University of Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Robert Montés-Mico, OD MPhil PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Optometry Research Group (GIO) Optics Department, University of Valencia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}