Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-01 @ 11:01 PM
Study NCT ID:
NCT02500368
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2015-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PChamberlain@coopervision.com', 'phone': '(925) 730-6754', 'title': 'Sr. Manager Clinical Research', 'organization': 'CooperVision Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From dispense up to one week for each study lenses', 'eventGroups': [{'id': 'EG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Lens dispense at baseline', 'categories': [{'measurements': [{'value': '90', 'spread': '11', 'groupId': 'OG000'}, {'value': '91', 'spread': '10', 'groupId': 'OG001'}]}]}, {'title': 'Lens insertion at 1 week', 'categories': [{'measurements': [{'value': '92', 'spread': '9', 'groupId': 'OG000'}, {'value': '90', 'spread': '14', 'groupId': 'OG001'}]}]}, {'title': 'Overall comfort at 1 week', 'categories': [{'measurements': [{'value': '79', 'spread': '15', 'groupId': 'OG000'}, {'value': '81', 'spread': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Lens dispense at baseline', 'categories': [{'measurements': [{'value': '94', 'spread': '10', 'groupId': 'OG000'}, {'value': '94', 'spread': '10', 'groupId': 'OG001'}]}]}, {'title': 'Lens insertion at 1 week', 'categories': [{'measurements': [{'value': '94', 'spread': '8', 'groupId': 'OG000'}, {'value': '92', 'spread': '12', 'groupId': 'OG001'}]}]}, {'title': 'Overall dryness at 1 week', 'categories': [{'measurements': [{'value': '75', 'spread': '19', 'groupId': 'OG000'}, {'value': '78', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Wettability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.09', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '1.18', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': '1 week', 'categories': [{'measurements': [{'value': '1.17', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '0.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surface Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Smooth', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Grainy', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Grade ratings category (smooth, grainy, or other)', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Surface Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Smooth', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'Grainy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Grade ratings category (smooth, grainy, or other)', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'High Contrast Acuity at High Room Illumination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': '1 week', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Logarithm of the Minimum Angle or Resolution (LogMAR) Chart', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Deposition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': '1 week', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Lenses', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Baseline, Blue specs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Fibers', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Nick', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '1 week, Blue specs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '1 week, Nick', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '1 week, Particles', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': 'Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings.', 'unitOfMeasure': 'Lenses', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lenses', 'denomUnitsSelected': 'Lenses'}, {'type': 'SECONDARY', 'title': 'Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'No decentration', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'N', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'T', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'S', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'I', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'N/S', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'N/I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'T/S', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'T/I', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.\n\n(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'No decentration', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'N', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'T', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'S', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'I', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'N/S', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'N/I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'T/S', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'T/I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.\n\n(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Post-blink Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': '1 week', 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Post-blink movement evaluated by estimating the distance the lens was moving immediately after a blink. Primary Gaze: (mm, 0.1 steps)', 'unitOfMeasure': 'mm steps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Tightness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '50.9', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '48.1', 'spread': '6.3', 'groupId': 'OG001'}]}]}, {'title': '1 week', 'categories': [{'measurements': [{'value': '48.8', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '47.9', 'spread': '6.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement.', 'unitOfMeasure': 'percentage of tightness', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Lens dispense at baseline', 'categories': [{'measurements': [{'value': '94', 'spread': '7', 'groupId': 'OG000'}, {'value': '93', 'spread': '9', 'groupId': 'OG001'}]}]}, {'title': 'Lens insertion at 1 week', 'categories': [{'measurements': [{'value': '95', 'spread': '7', 'groupId': 'OG000'}, {'value': '94', 'spread': '9', 'groupId': 'OG001'}]}]}, {'title': 'Overall vision quality at 1 week', 'categories': [{'measurements': [{'value': '88', 'spread': '12', 'groupId': 'OG000'}, {'value': '88', 'spread': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Subjective ratings scale (0-100): 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. Different time points were taken for vision quality: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ease of Lens Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '97', 'spread': '5', 'groupId': 'OG000'}, {'value': '92', 'spread': '10', 'groupId': 'OG001'}]}]}, {'title': '1 week', 'categories': [{'measurements': [{'value': '91', 'spread': '9', 'groupId': 'OG000'}, {'value': '90', 'spread': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Subjective ratings scale (0-100): 0=Could not place lens on eye, 20=Frequently takes multiple attempts to place on eye; often unsuccessful, 40=Frequently takes multiple attempts to place on eye, 60=Occasionally takes a few attempts to place on eye, 80=Rarely difficult to place on eye, 100=Always easy to place lens on eye', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ease of Lens Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'spread': '15', 'groupId': 'OG000'}, {'value': '90', 'spread': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Subjective ratings scale (0-100): 0=Could not remove lens from eye, 20=Frequently takes multiple attempts to remove from eye; often unsuccessful, 40=Frequently takes multiple attempts to remove from eye, 60=Occasionally takes a few attempts to remove from eye, 80=Rarely difficult to remove from eye, 100=Always easy to remove lens from eye.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Lens Fit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.35', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '3.33', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': '1 week', 'categories': [{'measurements': [{'value': '3.36', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '3.38', 'spread': '0.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Overall Lens Fit Scale 0-4, 0.25 steps 0=Very poor (lens should not be worn at all);\n\n1. Poor (lens could be worn with supervision only);\n2. Fair (would prefer to refit, but clinically acceptable);\n3. Good (fit could be slightly improved);\n4. Very good (optimal)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bulbar Hyperemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.96', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '1.96', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': '1 week', 'categories': [{'measurements': [{'value': '1.87', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '1.95', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Limbal Hyperemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.76', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '1.76', 'spread': '0.51', 'groupId': 'OG001'}]}]}, {'title': '1 week', 'categories': [{'measurements': [{'value': '1.68', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '0.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Corneal Dehydration Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Both eyes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'One eye', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Corneal Staining: Dehydration Staining: Yes/No', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Corneal Staining (Extent)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Central - baseline', 'categories': [{'measurements': [{'value': '1.21', 'spread': '4.97', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '4.97', 'groupId': 'OG001'}]}]}, {'title': 'Central - 1 week', 'categories': [{'measurements': [{'value': '0.64', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '4.97', 'groupId': 'OG001'}]}]}, {'title': 'Nasal - baseline', 'categories': [{'measurements': [{'value': '4.76', 'spread': '9.10', 'groupId': 'OG000'}, {'value': '4.76', 'spread': '9.10', 'groupId': 'OG001'}]}]}, {'title': 'Nasal - 1 week', 'categories': [{'measurements': [{'value': '2.20', 'spread': '6.68', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '4.79', 'groupId': 'OG001'}]}]}, {'title': 'Temporal - baseline', 'categories': [{'measurements': [{'value': '2.04', 'spread': '5.47', 'groupId': 'OG000'}, {'value': '2.04', 'spread': '5.47', 'groupId': 'OG001'}]}]}, {'title': 'Temporal - 1 week', 'categories': [{'measurements': [{'value': '1.38', 'spread': '4.05', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '2.92', 'groupId': 'OG001'}]}]}, {'title': 'Superior - baseline', 'categories': [{'measurements': [{'value': '2.15', 'spread': '7.21', 'groupId': 'OG000'}, {'value': '2.15', 'spread': '7.21', 'groupId': 'OG001'}]}]}, {'title': 'Superior - 1 week', 'categories': [{'measurements': [{'value': '1.75', 'spread': '4.42', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '2.07', 'groupId': 'OG001'}]}]}, {'title': 'Inferior - baseline', 'categories': [{'measurements': [{'value': '5.88', 'spread': '10.85', 'groupId': 'OG000'}, {'value': '5.88', 'spread': '10.85', 'groupId': 'OG001'}]}]}, {'title': 'Inferior - 1 week', 'categories': [{'measurements': [{'value': '6.48', 'spread': '11.52', 'groupId': 'OG000'}, {'value': '5.01', 'spread': '9.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Corneal staining extent, grade as % of each zone:\n\nC - Central, N - Nasal, T - Temporal, S - Superior, I - Interior', 'unitOfMeasure': 'percentage of cornea', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Conjunctival Indentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Nasal - baseline', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Nasal - 1 week', 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Temporal - baseline', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Temporal - 1 week', 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Superior - baseline', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Superior - 1 week', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Inferior - baseline', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Inferior - 1 week', 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week.', 'description': 'Conjunctival Indentation 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4, 0.5 steps; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Conjunctival Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.\n\nsilicone hydrogel lens (test): contact lens'}, {'id': 'OG001', 'title': 'Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.\n\nenfilcon A lens (control): contact lens'}], 'classes': [{'title': 'Nasal - baseline', 'categories': [{'measurements': [{'value': '0.48', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.45', 'groupId': 'OG001'}]}]}, {'title': 'Nasal - 1 week', 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Temporal - baseline', 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Temporal - 1 week', 'categories': [{'measurements': [{'value': '0.72', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Superior - baseline', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Superior - 1 week', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Inferior - baseline', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Inferior - 1 week', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Conjunctival Staining 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4; 0.5 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': 'Silicone Hydrogel Lens (Test), Then Enfilcon A Lens (Control)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week, then cross over to the enfilcon A lens (control).\n\nsilicone hydrogel lens (test): contact lens\n\nenfilcon A lens (control): contact lens'}, {'id': 'FG001', 'title': 'Enfilcon A Lens (Control), Then Silicone Hydrogel Lens (Test)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week, then cross over to the silicone hydrogel lens (test).\n\nenfilcon A lens (control): contact lens\n\nsilicone hydrogel lens (test): contact lens'}], 'periods': [{'title': 'First Intervention (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'One participant discontinued from the study as a screen failure before lens randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Baseline Characteristics', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) or enfilcon A lens (control) for 1 week during the cross over study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '55'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-19', 'studyFirstSubmitDate': '2015-07-14', 'resultsFirstSubmitDate': '2016-09-28', 'studyFirstSubmitQcDate': '2015-07-14', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-27', 'studyFirstPostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort', 'timeFrame': 'Baseline and 1 week', 'description': 'Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.'}, {'measure': 'Dryness', 'timeFrame': 'Baseline and 1 week', 'description': 'Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.'}], 'secondaryOutcomes': [{'measure': 'Lens Wettability', 'timeFrame': 'Baseline and 1 week', 'description': 'Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced.'}, {'measure': 'Surface Appearance', 'timeFrame': 'Baseline', 'description': 'Grade ratings category (smooth, grainy, or other)'}, {'measure': 'Surface Appearance', 'timeFrame': '1 week', 'description': 'Grade ratings category (smooth, grainy, or other)'}, {'measure': 'High Contrast Acuity at High Room Illumination', 'timeFrame': 'Baseline and 1 week', 'description': 'Logarithm of the Minimum Angle or Resolution (LogMAR) Chart'}, {'measure': 'Lens Deposition', 'timeFrame': 'Baseline and 1 week', 'description': 'Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced'}, {'measure': 'Lens Problems', 'timeFrame': 'Baseline and 1 week', 'description': 'Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings.'}, {'measure': 'Lens Centration', 'timeFrame': 'Baseline', 'description': 'Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.\n\n(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior'}, {'measure': 'Lens Centration', 'timeFrame': '1 week', 'description': 'Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.\n\n(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior'}, {'measure': 'Post-blink Movement', 'timeFrame': 'Baseline and 1 week', 'description': 'Post-blink movement evaluated by estimating the distance the lens was moving immediately after a blink. Primary Gaze: (mm, 0.1 steps)'}, {'measure': 'Lens Tightness', 'timeFrame': 'Baseline and 1 week', 'description': 'Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement.'}, {'measure': 'Visual Quality', 'timeFrame': 'Baseline and 1 week', 'description': 'Subjective ratings scale (0-100): 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. Different time points were taken for vision quality: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.'}, {'measure': 'Ease of Lens Insertion', 'timeFrame': 'Baseline and 1 week', 'description': 'Subjective ratings scale (0-100): 0=Could not place lens on eye, 20=Frequently takes multiple attempts to place on eye; often unsuccessful, 40=Frequently takes multiple attempts to place on eye, 60=Occasionally takes a few attempts to place on eye, 80=Rarely difficult to place on eye, 100=Always easy to place lens on eye'}, {'measure': 'Ease of Lens Removal', 'timeFrame': '1 week', 'description': 'Subjective ratings scale (0-100): 0=Could not remove lens from eye, 20=Frequently takes multiple attempts to remove from eye; often unsuccessful, 40=Frequently takes multiple attempts to remove from eye, 60=Occasionally takes a few attempts to remove from eye, 80=Rarely difficult to remove from eye, 100=Always easy to remove lens from eye.'}, {'measure': 'Overall Lens Fit', 'timeFrame': 'Baseline and 1 week', 'description': 'Overall Lens Fit Scale 0-4, 0.25 steps 0=Very poor (lens should not be worn at all);\n\n1. Poor (lens could be worn with supervision only);\n2. Fair (would prefer to refit, but clinically acceptable);\n3. Good (fit could be slightly improved);\n4. Very good (optimal)'}, {'measure': 'Bulbar Hyperemia', 'timeFrame': 'Baseline and 1 week', 'description': 'Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.'}, {'measure': 'Limbal Hyperemia', 'timeFrame': 'Baseline and 1 week', 'description': 'Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.'}, {'measure': 'Corneal Dehydration Staining', 'timeFrame': '1 week', 'description': 'Corneal Staining: Dehydration Staining: Yes/No'}, {'measure': 'Corneal Staining (Extent)', 'timeFrame': 'Baseline and 1 week', 'description': 'Corneal staining extent, grade as % of each zone:\n\nC - Central, N - Nasal, T - Temporal, S - Superior, I - Interior'}, {'measure': 'Conjunctival Indentation', 'timeFrame': 'Baseline and 1 week.', 'description': 'Conjunctival Indentation 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4, 0.5 steps; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe'}, {'measure': 'Conjunctival Staining', 'timeFrame': 'Baseline and 1 week', 'description': 'Conjunctival Staining 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4; 0.5 steps, 0=None,1=Minimal diffuse punctuate, 2=Coalescent punctuate, 3=Confluent, 4=Deep confluent'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'This is a 1-week dispensing, double-masked, randomized, bilateral study comparing the test lens against the control lens.', 'detailedDescription': 'The order of lens wear (test lens first, control lens second or control lens first, test lens second) will be selected according to a randomization table.\n\nBoth test and control lenses will be used in a daily wear modality for 1 week. It is anticipated that this study will involve following visits: Baseline (screening and dispense of 1st study pair of lenses, visit combined), 1-week visit (follow-up of the 1st study pair of lenses and dispense the 2nd study pair of lenses) and 2-week visit (1 week follow-up of the 2nd study pair of lenses).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n-A person is eligible for inclusion in the study if he/she:\n\n* Is at least 17 years of age and has full legal capacity to volunteer\n* Has read and understood the information consent letter\n* Is willing and able to follow instructions and maintain the appointment schedule\n* Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses\n* Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day.)\n\nExclusion Criteria:\n\n-A person will be excluded from the study if he/she:\n\n* Is participating in any concurrent clinical or research study\n* Has any known active\\* ocular disease and/or infection\n* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable\\*\\*\n* Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable\n* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study\n* Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).\n* Is aphakic\n* Has undergone corneal refractive surgery.\n\nFor the purposes of this study, active\\* ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active. Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)\n\nFor the purposes of this study, participants will be excluded\\*\\*, if currently taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants'}, 'identificationModule': {'nctId': 'NCT02500368', 'briefTitle': 'A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week', 'orgStudyIdInfo': {'id': 'CV-15-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'silicone hydrogel lens (test)', 'description': 'Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.', 'interventionNames': ['Device: silicone hydrogel lens (test)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'enfilcon A lens (control)', 'description': 'Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.', 'interventionNames': ['Device: enfilcon A lens (control)']}], 'interventions': [{'name': 'silicone hydrogel lens (test)', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['silicone hydrogel lens (test)']}, {'name': 'enfilcon A lens (control)', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['enfilcon A lens (control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L 3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Center for Contact Lens Research, University of Waterloo', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'Lyndon Jones, PhD FCO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Contact Lens Research, University of Waterloo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}