Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT03372551
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2017-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens
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': 'mnguyen@coopervision.com', 'phone': '925-730-6716', 'title': 'Myhanh Nguyen, Sr. Optometrist', 'organization': 'Coopervision'}, 'certainAgreement': {'otherDetails': 'Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From dispense to completion of follow up, up to 2 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Somofilcon A 1 Day Test Lens', 'description': 'Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.\n\nsomofilcon A 1 day test lens: Contact lens\n\nsomofilcon A 1 day control lens: Contact lens', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Somofilcon A 1 Day Control Lens', 'description': 'Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.\n\nsomofilcon A 1 day test lens: Contact lens\n\nsomofilcon A 1 day control lens: Contact lens', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A 1 Day Test Lens', 'description': 'Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.\n\nsomofilcon A 1 day test lens: Contact lens\n\nsomofilcon A 1 day control lens: Contact lens'}, {'id': 'OG001', 'title': 'Somofilcon A 1 Day Control Lens', 'description': 'Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.\n\nsomofilcon A 1 day test lens: Contact lens\n\nsomofilcon A 1 day control lens: Contact lens'}], 'classes': [{'title': 'Comfort at Dispense', 'categories': [{'measurements': [{'value': '90', 'spread': '8', 'groupId': 'OG000'}, {'value': '89', 'spread': '11', 'groupId': 'OG001'}]}]}, {'title': 'Comfort at Insertion after 1 week', 'categories': [{'measurements': [{'value': '86', 'spread': '11', 'groupId': 'OG000'}, {'value': '87', 'spread': '16', 'groupId': 'OG001'}]}]}, {'title': 'Comfort during day after 1 week', 'categories': [{'measurements': [{'value': '84', 'spread': '11', 'groupId': 'OG000'}, {'value': '86', 'spread': '11', 'groupId': 'OG001'}]}]}, {'title': 'Comfort end day after 1 week', 'categories': [{'measurements': [{'value': '75', 'spread': '15', 'groupId': 'OG000'}, {'value': '78', 'spread': '16', 'groupId': 'OG001'}]}]}, {'title': 'Overall comfort after 1 week of lens wear', 'categories': [{'measurements': [{'value': '82', 'spread': '11', 'groupId': 'OG000'}, {'value': '85', 'spread': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 week', 'description': 'Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A 1 Day Test / Control Contact Lens', 'description': 'Each subjects randomized to wear either the somofilcon A 1 day test or somofilcon A 1 day control as a matched pair and cross over to second matched pair.\n\nsomofilcon A 1 day test lens: Test / Contact lens\n\nsomofilcon A 1 day control lens: Test / Contact lens'}], 'classes': [{'title': 'Strongly preferred somofilcon A 1 Day Test lens', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Slightly preferred somofilcon A 1 Day Test lens', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'No preference', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Slightly preferred somofilcon A 1 Day Control lens', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Strongly preferred somofilcon A 1 Day control lens', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 week', 'description': 'Overall lens that subject prefers or no preference', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A 1 Day Test Lens Dispense', 'description': 'Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.\n\nsomofilcon A 1 day test lens: Contact lens\n\nsomofilcon A 1 day control lens: Contact lens'}, {'id': 'OG001', 'title': 'Somofilcon A 1 Day Test Lens 1 Week', 'description': 'Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.\n\nsomofilcon A 1 day test lens: Contact lens\n\nsomofilcon A 1 day control lens: Contact lens'}, {'id': 'OG002', 'title': 'Somofilcon A 1 Day Control Lens Dispense', 'description': 'Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.\n\nsomofilcon A 1 day test lens: Contact lens\n\nsomofilcon A 1 day control lens: Contact lens'}, {'id': 'OG003', 'title': 'Somofilcon A 1 Day Control Lens 1 Week', 'description': 'Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.\n\nsomofilcon A 1 day test lens: Contact lens\n\nsomofilcon A 1 day control lens: Contact lens'}], 'classes': [{'title': 'High Illumination high contrast monocular', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-0.11', 'spread': '0.07', 'groupId': 'OG002'}, {'value': '-0.11', 'spread': '0.06', 'groupId': 'OG003'}]}]}, {'title': 'High Illumination high contrast binocular', 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-0.15', 'spread': '0.06', 'groupId': 'OG002'}, {'value': '-0.16', 'spread': '0.06', 'groupId': 'OG003'}]}]}, {'title': 'Low Illumination high contrast monocular', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.07', 'groupId': 'OG002'}, {'value': '-0.10', 'spread': '0.06', 'groupId': 'OG003'}]}]}, {'title': 'Low Illumination high contrast binocular', 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '0.06', 'groupId': 'OG002'}, {'value': '-0.14', 'spread': '0.05', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 week', 'description': 'Visual acuity measured in logMAR', 'unitOfMeasure': 'Log(MAR)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Dispensing - n=32 participants total, 1 week = 31 participants total due to a nonserious adverse events for somofilcon A 1 day test lens.'}, {'type': 'PRIMARY', 'title': 'Subjective Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon 1 Day Test Lens: Vision Quality/Clarity During Day', 'description': 'Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.\n\nsomofilcon A 1 day test lens: Contact lens\n\nsomofilcon A 1 day control lens: Contact lens'}, {'id': 'OG001', 'title': 'Somofilcon A Control Lens: Vision Quality/Clarity During Day', 'description': 'Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.\n\nsomofilcon A 1 day test lens: Contact lens\n\nsomofilcon A 1 day control lens: Contact lens'}], 'classes': [{'title': 'Dispense', 'categories': [{'measurements': [{'value': '92', 'spread': '9', 'groupId': 'OG000'}, {'value': '92', 'spread': '6', 'groupId': 'OG001'}]}]}, {'title': '1 week', 'categories': [{'measurements': [{'value': '88', 'spread': '12', 'groupId': 'OG000'}, {'value': '91', 'spread': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 week', 'description': 'Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Corneal Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'units': 'Eye', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A 1 Day Test Lens', 'description': 'Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.\n\nsomofilcon A 1 day test lens: Contact lens\n\nsomofilcon A 1 day control lens: Contact lens'}, {'id': 'OG001', 'title': 'Somofilcon A 1 Day Control Lens', 'description': 'Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.\n\nsomofilcon A 1 day test lens: Contact lens\n\nsomofilcon A 1 day control lens: Contact lens'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'units': 'Eye', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': '1 week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'units': 'Eye', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 week', 'description': 'Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eye', 'denomUnitsSelected': 'Eye', 'populationDescription': "Baseline n=32 participants / 64 eyes, 1 week n = 31 participants / 62 eyes due to non-serious adverse event participant's measurements weren't completed."}, {'type': 'PRIMARY', 'title': 'Conjunctival Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A 1 Day Test Lens', 'description': 'Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.\n\nsomofilcon A 1 day test lens: Contact lens\n\nsomofilcon A 1 day control lens: Contact lens'}, {'id': 'OG001', 'title': 'Somofilcon A 1 Day Control Lens', 'description': 'Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.\n\nsomofilcon A 1 day test lens: Contact lens\n\nsomofilcon A 1 day control lens: Contact lens'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': '1 week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.72', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 week', 'description': 'Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': "Baseline n=32 participants / 64 eyes, 1 week n= 31 participants / 62 eyes due to non-serious adverse event participant's measurements weren't completed."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Somofilcon A 1 Day Test Lens First, Then Control 1 Day Lens', 'description': 'Subjects wear the somofilcon A 1 day Test Lens first for one week, then somofilcon A 1 day Control lens for one week.\n\nsomofilcon A 1 day test lens: Contact lens\n\nsomofilcon A 1 day control lens: Contact lens'}, {'id': 'FG001', 'title': 'Somofilcon A 1 Day Control Lens First, Then 1 Day Test Lens', 'description': 'Subjects wear the somofilcon A 1 day Control lens first for one week, then somofilcon A 1 day Test lens for one week.\n\nsomofilcon A 1 day test lens: Contact lens\n\nsomofilcon A 1 day control lens: Contact lens'}], 'periods': [{'title': 'First Intervention (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Three (3) subjects did not meet inclusion criteria and were excluded from the analysis. One subject was enrolled and later discontinued.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Somofilcon A 1 Day Test vs Control Contact Lens', 'description': 'Each subjects randomized to wear either the test or control as a matched pair and cross over to second matched pair.\n\nsomofilcon A 1 day test lens: Test / Contact lens\n\nsomofilcon A 1 day control lens: Test / Contact lens'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-20', 'size': 1261240, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-09T12:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Both the participants and study investigators will be masked to the randomization schedule of the contact lenses used.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This will be a, prospective, double-masked, randomized, bilateral, 1 week cross-over, dispensing study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'dispFirstSubmitDate': '2019-01-21', 'completionDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2017-12-08', 'dispFirstSubmitQcDate': '2019-01-29', 'resultsFirstSubmitDate': '2019-02-21', 'studyFirstSubmitQcDate': '2017-12-08', 'dispFirstPostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-28', 'studyFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort', 'timeFrame': 'up to 1 week', 'description': 'Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever)'}, {'measure': 'Preference', 'timeFrame': 'up to 1 week', 'description': 'Overall lens that subject prefers or no preference'}, {'measure': 'Vision', 'timeFrame': 'Up to 1 week', 'description': 'Visual acuity measured in logMAR'}, {'measure': 'Subjective Vision', 'timeFrame': 'up to 1 week', 'description': 'Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time)'}, {'measure': 'Corneal Staining', 'timeFrame': 'up to 1 week', 'description': 'Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps'}, {'measure': 'Conjunctival Staining', 'timeFrame': 'up to 1 week', 'description': 'Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft contact lens.', 'detailedDescription': 'The purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, bilateral, cross-over, dispensing study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is at least 17 years of age and has full legal capacity to volunteer;\n* Has had a self-reported oculo-visual examination in the last two years;\n* Has read, understood, and signed the information consent letter;\n* Is willing and able to follow instructions and maintain the appointment schedule;\n* Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity);\n* Must be able to achieve 20/30 or better (in each eye) with the study lenses;\n* Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;\n* Requires spectacle lens powers between -0.75 and -06.50 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\nExclusion Criteria:\n\n* Is presently participating in any other clinical or research study including eye related clinical or research study;\n* Has never worn contact lenses before.\n* Has any systemic disease affecting ocular health.\n* Has any active\\* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.\n* Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.\n* Has any known sensitivity to fluorescein dye or products to be used in the study.\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 pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).'}, 'identificationModule': {'nctId': 'NCT03372551', 'briefTitle': 'Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Comparison of Daily Disposable Invigor I (Test) and Select 1 Day Lenses', 'orgStudyIdInfo': {'id': 'CV-16-43'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'somofilcon A 1 day test lens', 'description': 'Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.', 'interventionNames': ['Device: somofilcon A 1 day test lens', 'Device: somofilcon A 1 day control lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'somofilcon A 1 day control lens', 'description': 'Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.', 'interventionNames': ['Device: somofilcon A 1 day test lens', 'Device: somofilcon A 1 day control lens']}], 'interventions': [{'name': 'somofilcon A 1 day test lens', 'type': 'DEVICE', 'otherNames': ['somofilcon A daily disposable test soft contact lens', 'Invigor I', 'Test lens'], 'description': 'Contact lens', 'armGroupLabels': ['somofilcon A 1 day control lens', 'somofilcon A 1 day test lens']}, {'name': 'somofilcon A 1 day control lens', 'type': 'DEVICE', 'otherNames': ['somofilcon A daily disposable control soft contact lens', 'Select 1-Day', 'Control lens'], 'description': 'Contact lens', 'armGroupLabels': ['somofilcon A 1 day control lens', 'somofilcon A 1 day test lens']}]}, '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}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}