Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT03499067
Status:
COMPLETED
Last Update Posted:
2020-08-26
First Post:
2018-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Dispensing Clinical Trial of Test Contact Lens Against Marketed Contact Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mnguyen@coopervision.com', 'phone': '925-730-6716', 'title': 'Myhanh Nguyen', 'organization': 'CooperVision, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From dispense up to 4-weeks on each type of lenses', 'eventGroups': [{'id': 'EG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lens Surface Wettability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.26', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '3.26', 'spread': '0.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \\<\\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Surface Wettability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.18', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '3.25', 'spread': '0.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-weeks', 'description': 'Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \\<\\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Surface Wettability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.11', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '3.01', 'spread': '0.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-weeks', 'description': 'Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \\<\\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Surface Deposits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits, 1: 5 or less small deposits (\\<0.1mm), 2: \\>5 deposits of \\<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Surface Deposits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-weeks', 'description': 'Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (\\<0.1mm), 2: \\>5 deposits of \\<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Surface Deposits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.35', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-weeks', 'description': 'Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (\\<0.1mm), 2: \\>5 deposits of \\<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Lens Fit Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.30', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '3.27', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Lens Fit Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.28', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '3.31', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-Weeks', 'description': "Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Lens Fit Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.31', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '3.13', 'spread': '0.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-Weeks', 'description': "Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'title': 'Optimal', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Slightly Decentered', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Extremely Decentered', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\\<0.5mm), Extremely decentered (\\>0.5mm)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'title': 'Optimal', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Slightly Decentered', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Extremely Decentered', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-weeks', 'description': 'Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\\<0.5mm), Extremely decentered (\\>0.5mm)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'title': 'Optimal', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Slightly Decentered', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Extremely Decentered', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-weeks', 'description': 'Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\\<0.5mm), Extremely decentered (\\>0.5mm)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bulbar Conjunctiva Hyperaemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '1.11', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '0.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bulbar Conjunctiva Hyperaemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '1.20', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-weeks', 'description': 'Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bulbar Conjunctiva Hyperaemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '1.15', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-weeks', 'description': 'Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Limbal Conjunctiva Hyperaemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.57', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Limbal Conjunctiva Hyperaemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '0.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-weeks', 'description': 'Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Limbal Conjunctiva Hyperaemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Lens', 'description': 'Subjects were randomized to wear test contact lens for one month in this cross-over study.\n\nTest lens: Contact lens'}, {'id': 'OG001', 'title': 'Control Lens', 'description': 'Subjects were randomized to wear control contact lens for one month in this cross-over study.\n\nControl lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.65', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-weeks', 'description': 'Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test Lens Then Control Lens', 'description': 'Subjects were randomized to wear test lens for one month then control lens for one month during the cross-over study.\n\nTest lens: Contact lens\n\nControl lens: Contact lens'}, {'id': 'FG001', 'title': 'Control Lens Then Test Lens', 'description': 'Subjects were randomized to wear control lens for one month then test lens for one month during the cross-over study.\n\nTest lens: Contact lens\n\nControl lens: Contact lens'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Total participants'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '58', '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': '58', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27', 'spread': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', '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': '58', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-10', 'size': 2613252, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-23T20:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'This will be a double-masked study in which both participant and investigator will be masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each subject will be randomized to wear the test or control contact lens for 1 month and then crossed-over to wear the other contact lens for 1 month.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-13', 'studyFirstSubmitDate': '2018-04-09', 'resultsFirstSubmitDate': '2020-07-21', 'studyFirstSubmitQcDate': '2018-04-13', 'lastUpdatePostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-13', 'studyFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lens Surface Wettability', 'timeFrame': 'Baseline', 'description': 'Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \\<\\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)'}, {'measure': 'Lens Surface Wettability', 'timeFrame': '2-weeks', 'description': 'Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \\<\\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)'}, {'measure': 'Lens Surface Wettability', 'timeFrame': '4-weeks', 'description': 'Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \\<\\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)'}, {'measure': 'Lens Surface Deposits', 'timeFrame': 'Baseline', 'description': 'Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits, 1: 5 or less small deposits (\\<0.1mm), 2: \\>5 deposits of \\<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)'}, {'measure': 'Lens Surface Deposits', 'timeFrame': '2-weeks', 'description': 'Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (\\<0.1mm), 2: \\>5 deposits of \\<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface).'}, {'measure': 'Lens Surface Deposits', 'timeFrame': '4-weeks', 'description': 'Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (\\<0.1mm), 2: \\>5 deposits of \\<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)'}, {'measure': 'Overall Lens Fit Acceptance', 'timeFrame': 'Baseline', 'description': "Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)"}, {'measure': 'Overall Lens Fit Acceptance', 'timeFrame': '2-Weeks', 'description': "Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)"}, {'measure': 'Overall Lens Fit Acceptance', 'timeFrame': '4-Weeks', 'description': "Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)"}, {'measure': 'Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration', 'timeFrame': 'Baseline', 'description': 'Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\\<0.5mm), Extremely decentered (\\>0.5mm)'}, {'measure': 'Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration', 'timeFrame': '2-weeks', 'description': 'Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\\<0.5mm), Extremely decentered (\\>0.5mm)'}, {'measure': 'Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration', 'timeFrame': '4-weeks', 'description': 'Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\\<0.5mm), Extremely decentered (\\>0.5mm)'}], 'secondaryOutcomes': [{'measure': 'Bulbar Conjunctiva Hyperaemia', 'timeFrame': 'Baseline', 'description': 'Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)'}, {'measure': 'Bulbar Conjunctiva Hyperaemia', 'timeFrame': '2-weeks', 'description': 'Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)'}, {'measure': 'Bulbar Conjunctiva Hyperaemia', 'timeFrame': '4-weeks', 'description': 'Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)'}, {'measure': 'Limbal Conjunctiva Hyperaemia', 'timeFrame': 'Baseline', 'description': 'Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)'}, {'measure': 'Limbal Conjunctiva Hyperaemia', 'timeFrame': '2-weeks', 'description': 'Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)'}, {'measure': 'Limbal Conjunctiva Hyperaemia', 'timeFrame': '4-weeks', 'description': 'Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isUnapprovedDevice': True}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed lens (control), when worn on a daily basis for 1 month.', 'detailedDescription': 'Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed silicone- hydrogel contact lens (control), when worn on a daily basis for 1 month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has had a self-reported oculo-visual examination in the last two years.\n* Is at least 18 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 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.\n* Currently wears soft contact lenses.\n* Requires spectacle lens powers between -0.75 to -6.50 diopters sphere (0.25D steps).\n* Has no more than 0.75 diopters of refractive astigmatism.\n* Has clear corneas and no active ocular disease.\n* Has not worn lenses for at least 12 hours before the examination.\n* Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit\n\nExclusion Criteria:\n\n* Has never worn contact lenses before.\n* Has any systemic disease affecting ocular health.\n* Is using any systemic or topical medications that will affect ocular health.\n* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.\n* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.\n* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.\n* Is aphakic.\n* Has undergone corneal refractive surgery.\n* Is participating in any other type of eye related clinical or research study.\n* Known allergy to a product used in this study (ex. Shellfish allergy)\n* Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).'}, 'identificationModule': {'nctId': 'NCT03499067', 'briefTitle': 'A Dispensing Clinical Trial of Test Contact Lens Against Marketed Contact Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'A Dispensing Clinical Trial of Invigor I Lens Against Clariti Lens', 'orgStudyIdInfo': {'id': 'CV-18-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test lens', 'description': 'Subjects wearing the test contact lens either as first or second pair during the cross-over study.', 'interventionNames': ['Device: Test lens', 'Device: Control lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control lens', 'description': 'Subjects wearing the control contact lens either as first or second pair during the cross-over study.', 'interventionNames': ['Device: Test lens', 'Device: Control lens']}], 'interventions': [{'name': 'Test lens', 'type': 'DEVICE', 'otherNames': ['Invigor I lens'], 'description': 'Contact lens', 'armGroupLabels': ['Control lens', 'Test lens']}, {'name': 'Control lens', 'type': 'DEVICE', 'otherNames': ['Clariti lens'], 'description': 'Contact lens', 'armGroupLabels': ['Control lens', 'Test lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Research Center, University of California, Berkeley', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'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}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}