Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-02-01 @ 3:28 AM
Study NCT ID:
NCT02436005
Status:
COMPLETED
Last Update Posted:
2020-11-18
First Post:
2015-05-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dispensing Study for the Phenacite Project
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PChamberlain@coopervision.com', 'phone': '925 730-6754', 'title': 'Paul Chamberlain', 'organization': 'CooperVision Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From dispense up to two weeks on each study lenses, a total of four weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly for two weeks.\n\nPhenacite: contact lenses', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear comfilcon A contact lenses binocularly for two weeks.\n\ncomfilcon A: contact lenses binocularly.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Ratings of Lens Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '86.50', 'spread': '14.99', 'groupId': 'OG000'}, {'value': '90.13', 'spread': '8.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Subjective Ratings of Lens Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '66.46', 'spread': '25.22', 'groupId': 'OG000'}, {'value': '71.71', 'spread': '24.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 Weeks', 'description': 'Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Over Refraction for Optimized Distance Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'title': 'OD (oculus dexter - right eye)', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'OS (Oculus sinister - left eye)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Over Refraction for optimized distance acuity measured using logMAR', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Binocular Distance Visual Acuity - High Illumination High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 5 minutes of lens dispense)', 'description': 'Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Binocular Distance Visual Acuity - High Illumination High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Binocular Distance Visual Acuity - Low Illumination High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 5 minutes of lens dispense)', 'description': 'Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Binocular Distance Visual Acuity - Low Illumination High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Binocular Near Visual Acuity - High Illumination High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 5 minutes of lens dispense)', 'description': 'Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Binocular Near Visual Acuity - High Illumination High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Binocular Near Visual Acuity - Low Illumination High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 5 minutes of lens dispense)', 'description': 'Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Binocular Near Visual Acuity - Low Illumination High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Fit - Post Blink Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'title': 'OD (oculus dexter - right eye)', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'OS(oculus sinister - left eye)', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One Subject was excluded from the analysis'}, {'type': 'SECONDARY', 'title': 'Lens Fit - Post Blink Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'title': 'OD (oculus dexter - right eye)', 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'OS (oculus sinister - left eye)', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Push - Up Test for Lens Tightness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'title': 'OD (oculus Dexter - Right eye)', 'categories': [{'measurements': [{'value': '50.43', 'spread': '5.09', 'groupId': 'OG000'}, {'value': '51.52', 'spread': '5.40', 'groupId': 'OG001'}]}]}, {'title': 'OS (Oculus Sinister - Left eye)', 'categories': [{'measurements': [{'value': '49.78', 'spread': '4.77', 'groupId': 'OG000'}, {'value': '50.65', 'spread': '4.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One Subject was excluded from the analysis'}, {'type': 'SECONDARY', 'title': 'Push - Up Test for Lens Tightness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'title': 'OD (oculus dexter - right eye)', 'categories': [{'measurements': [{'value': '52.83', 'spread': '7.64', 'groupId': 'OG000'}, {'value': '49.35', 'spread': '4.50', 'groupId': 'OG001'}]}]}, {'title': 'OS (Oculus Sinister - Left Eye)', 'categories': [{'measurements': [{'value': '51.30', 'spread': '5.94', 'groupId': 'OG000'}, {'value': '48.70', 'spread': '4.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Mobility Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'title': 'OD (oculus dexter - Right Eye)', 'categories': [{'measurements': [{'value': '3.07', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '2.99', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': 'OS (Oculus Sinister - Left eye)', 'categories': [{'measurements': [{'value': '3.09', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '3.01', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (\\>1mm) on versions in all directions in 0.25 steps', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One Subject was excluded from the analysis'}, {'type': 'SECONDARY', 'title': 'Lens Mobility Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'title': 'OD (oculus dexter - right eye)', 'categories': [{'measurements': [{'value': '2.91', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '3.08', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'OS (oculus sinister - left eye)', 'categories': [{'measurements': [{'value': '3.00', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '3.10', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (\\>1mm) on versions in all directions in 0.25 steps', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Lens Fit Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'title': 'OD (oculus dexter - right eye)', 'categories': [{'measurements': [{'value': '3.35', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'OS ( oculus sinister - Left Eye)', 'categories': [{'measurements': [{'value': '3.37', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': "Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One Subject was excluded from the analysis'}, {'type': 'SECONDARY', 'title': 'Overall Lens Fit Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'title': 'OD (oculus dexter- right eye)', 'categories': [{'measurements': [{'value': '3.25', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '3.34', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'OS (oculus sinister - left eye)', 'categories': [{'measurements': [{'value': '3.32', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '3.36', 'spread': '0.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': "Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Ratings for Vision Quality - Distance Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '86.58', 'spread': '17.13', 'groupId': 'OG000'}, {'value': '91.3', 'spread': '10.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One Subject was excluded from the analysis'}, {'type': 'SECONDARY', 'title': 'Subjective Ratings for Vision Quality - Distance Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '85.33', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '88.88', 'spread': '15.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Ratings for Vision Quality - Near Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '92.00', 'spread': '11.16', 'groupId': 'OG000'}, {'value': '92.63', 'spread': '7.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One Subject was excluded from the analysis'}, {'type': 'SECONDARY', 'title': 'Subjective Ratings for Vision Quality - Near Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '84.83', 'spread': '23.88', 'groupId': 'OG000'}, {'value': '85.88', 'spread': '21.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Ratings for Vision Quality - Computer Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '92.79', 'spread': '10.75', 'groupId': 'OG000'}, {'value': '93.17', 'spread': '8.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One Subject was excluded from the analysis'}, {'type': 'SECONDARY', 'title': 'Subjective Ratings for Vision Quality - Computer Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '85.04', 'spread': '21.27', 'groupId': 'OG000'}, {'value': '89.08', 'spread': '15.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Ratings for Vision Quality - Overall Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '91.00', 'spread': '10.64', 'groupId': 'OG000'}, {'value': '92.67', 'spread': '7.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One Subject was excluded from the analysis'}, {'type': 'SECONDARY', 'title': 'Subjective Ratings for Vision Quality - Overall Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '85.96', 'spread': '17.66', 'groupId': 'OG000'}, {'value': '88.63', 'spread': '14.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Corneal Staining Extent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'title': 'Central', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Nasal', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Temporal', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Superior', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Inferior', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Corneal staining extent was assessed on a scale of 0-4 (0-No Staining, 1 - 1-15% of area, 2- 16-30% of area, 3- 31-45% of area, 4- \\>45% of area', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Conjunctival Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.\n\nPhenacite: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.\n\ncomfilcon A: contact lenses'}], 'classes': [{'title': 'Nasal', 'categories': [{'measurements': [{'value': '0.48', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Temporal', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Superior', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Inferior', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phenacite Then Comfilcon A', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly for two weeks then cross-over to comfilcon A lenses for two weeks.\n\nPhenacite: contact lenses comfilcon A: Contact Lenses'}, {'id': 'FG001', 'title': 'Comfilcon A Then Phenacite', 'description': 'Subjects will be randomized to wear comfilcon A contact lenses for two weeks then cross-over to Phenacite Lenses for two weeks.\n\ncomfilcon A: Contact Lenses Phenacite : Contact Lenses'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Subjects will be randomized to wear the Phenacite and comfilcon A contact lenses binocularly for two weeks.\n\nPhenacite: contact lenses (Not the final Design - Further clinical studies were conducted to validate the new design)\n\ncomfilcon A: contact lenses'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27', 'spread': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-30', 'studyFirstSubmitDate': '2015-05-01', 'resultsFirstSubmitDate': '2020-10-09', 'studyFirstSubmitQcDate': '2015-05-01', 'lastUpdatePostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-09', 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Ratings of Lens Comfort', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)'}, {'measure': 'Subjective Ratings of Lens Comfort', 'timeFrame': '2 Weeks', 'description': 'Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)'}, {'measure': 'Over Refraction for Optimized Distance Acuity', 'timeFrame': '2 weeks', 'description': 'Over Refraction for optimized distance acuity measured using logMAR'}, {'measure': 'Binocular Distance Visual Acuity - High Illumination High Contrast', 'timeFrame': 'Baseline (after 5 minutes of lens dispense)', 'description': 'Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR'}, {'measure': 'Binocular Distance Visual Acuity - High Illumination High Contrast', 'timeFrame': '2 weeks', 'description': 'Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR'}, {'measure': 'Binocular Distance Visual Acuity - Low Illumination High Contrast', 'timeFrame': 'Baseline (after 5 minutes of lens dispense)', 'description': 'Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR'}, {'measure': 'Binocular Distance Visual Acuity - Low Illumination High Contrast', 'timeFrame': '2 weeks', 'description': 'Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR'}, {'measure': 'Binocular Near Visual Acuity - High Illumination High Contrast', 'timeFrame': 'Baseline (after 5 minutes of lens dispense)', 'description': 'Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR'}, {'measure': 'Binocular Near Visual Acuity - High Illumination High Contrast', 'timeFrame': '2 weeks', 'description': 'Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR'}, {'measure': 'Binocular Near Visual Acuity - Low Illumination High Contrast', 'timeFrame': 'Baseline (after 5 minutes of lens dispense)', 'description': 'Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR'}, {'measure': 'Binocular Near Visual Acuity - Low Illumination High Contrast', 'timeFrame': '2 weeks', 'description': 'Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR'}], 'secondaryOutcomes': [{'measure': 'Lens Fit - Post Blink Movement', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)'}, {'measure': 'Lens Fit - Post Blink Movement', 'timeFrame': '2 weeks', 'description': 'Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)'}, {'measure': 'Push - Up Test for Lens Tightness', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement'}, {'measure': 'Push - Up Test for Lens Tightness', 'timeFrame': '2 weeks', 'description': 'Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement'}, {'measure': 'Lens Mobility Rating', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (\\>1mm) on versions in all directions in 0.25 steps'}, {'measure': 'Lens Mobility Rating', 'timeFrame': '2 weeks', 'description': 'Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (\\>1mm) on versions in all directions in 0.25 steps'}, {'measure': 'Overall Lens Fit Acceptance', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': "Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps"}, {'measure': 'Overall Lens Fit Acceptance', 'timeFrame': '2 weeks', 'description': "Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps"}, {'measure': 'Subjective Ratings for Vision Quality - Distance Vision', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time'}, {'measure': 'Subjective Ratings for Vision Quality - Distance Vision', 'timeFrame': '2 weeks', 'description': 'Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time'}, {'measure': 'Subjective Ratings for Vision Quality - Near Vision', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time'}, {'measure': 'Subjective Ratings for Vision Quality - Near Vision', 'timeFrame': '2 weeks', 'description': 'Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time'}, {'measure': 'Subjective Ratings for Vision Quality - Computer Vision', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time'}, {'measure': 'Subjective Ratings for Vision Quality - Computer Vision', 'timeFrame': '2 weeks', 'description': 'Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time'}, {'measure': 'Subjective Ratings for Vision Quality - Overall Vision', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time'}, {'measure': 'Subjective Ratings for Vision Quality - Overall Vision', 'timeFrame': '2 weeks', 'description': 'Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time'}, {'measure': 'Corneal Staining Extent', 'timeFrame': '2 weeks', 'description': 'Corneal staining extent was assessed on a scale of 0-4 (0-No Staining, 1 - 1-15% of area, 2- 16-30% of area, 3- 31-45% of area, 4- \\>45% of area'}, {'measure': 'Conjunctival Staining', 'timeFrame': '2 weeks', 'description': 'Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Ametropia']}, 'descriptionModule': {'briefSummary': 'Dispensing Study for the Phenacite Project.\n\nThe investigational test lens was not the final optical design and the study was not used for design validation.', 'detailedDescription': 'Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Oculo-visual examination in the last two years\n* Between 18 and 35 years of age and has full legal capacity to volunteer\n* Has read and understood the informed consent letter\n* Is willing and able to follow instructions and maintain the appointment schedule\n* Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected\n* Currently wears, or has previously successfully worn, soft contact lenses between -1.00D and -4.00D\n* Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder ≤-0.75\n* Has not worn lenses for at least 12 hours before the initial visit\n* Has a subjective response at baseline, which indicates suitability for this study\n* Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period\n* Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week.\n\nExclusion Criteria:\n\n* Has never worn contact lenses before\n* Any systemic disease affecting ocular health\n* Is using any systemic or topical medications that will affect ocular health\n* Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.\n* Has any ocular pathology or anomaly that would affect the wearing of the lenses\n* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye\n* Is aphakic\n* Has anisometropia of \\>1.00\n* Has undergone corneal refractive surgery\n* Has strabismus\n* Has any ocular amblyopia \\>= 1line of HC Visual Acuity\n* Is participating in any other type of eye related clinical or research study\n* Has participated in study CV-14-32.'}, 'identificationModule': {'nctId': 'NCT02436005', 'briefTitle': 'Dispensing Study for the Phenacite Project', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Dispensing Study for the Phenacite Project', 'orgStudyIdInfo': {'id': 'CV-15-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phenacite', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.', 'interventionNames': ['Device: Phenacite', 'Device: comfilcon A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'comfilcon A', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.', 'interventionNames': ['Device: Phenacite', 'Device: comfilcon A']}], 'interventions': [{'name': 'Phenacite', 'type': 'DEVICE', 'description': 'Subjects will be randomized to wear the Phenacite contact lenses binocularly.', 'armGroupLabels': ['Phenacite', 'comfilcon A']}, {'name': 'comfilcon A', 'type': 'DEVICE', 'description': 'Subjects will be randomized to wear the comfilcon A contact lenses binocularly.', 'armGroupLabels': ['Phenacite', 'comfilcon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47405', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}], 'overallOfficials': [{'name': 'Pete Kollbaun, OD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CORL Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}