Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-07 @ 6:39 AM
Study NCT ID:
NCT02699593
Status:
COMPLETED
Last Update Posted:
2017-07-12
First Post:
2016-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Approved Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'BPALL@its.jnj.com', 'phone': '904 443-1290', 'title': 'Brian Pall, OD, MS, FAAO -Sr. Principal Research Optometrist', 'organization': 'Johnson & Johnson Vision Care Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Throughout the duration of the study. Approximately 6 weeks per subject.', 'eventGroups': [{'id': 'EG000', 'title': 'Senofilcon A (Test)', 'description': 'Subjects that wore the test lens senofilcon A during either the first or second period of the study.', 'otherNumAtRisk': 141, 'otherNumAffected': 0, 'seriousNumAtRisk': 141, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Senofilcon A (Control)', 'description': 'Subjects that wore the control lens senofilcon A lens during the first or second period of the study.', 'otherNumAtRisk': 141, 'otherNumAffected': 0, 'seriousNumAtRisk': 141, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Contact Lens Wearing Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A (Test)', 'description': 'Subjects that wore the test lens senofilcon A during either the first or second period of the study.'}, {'id': 'OG001', 'title': 'Senofilcon A (Control)', 'description': 'Subjects that wore the control lens senofilcon A lens during the first or second period of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.55', 'spread': '1.534', 'groupId': 'OG000'}, {'value': '14.63', 'spread': '1.516', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-week follow-up', 'description': 'Contact lens wearing time was collected for each subject at the 2-week follow-up evaluation. The average contact lens wearing time in hours was reported for each lens.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects that completed all study visits without a major protocol deviation.'}, {'type': 'PRIMARY', 'title': 'Visual Acuity (LogMAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A (Test)', 'description': 'Subjects that wore the test lens senofilcon A during either the first or second period of the study.'}, {'id': 'OG001', 'title': 'Senofilcon A (Control)', 'description': 'Subjects that wore the control lens senofilcon A lens during the first or second period of the study.'}], 'classes': [{'title': 'Bright Low Contrast', 'categories': [{'measurements': [{'value': '0.121', 'spread': '0.0905', 'groupId': 'OG000'}, {'value': '0.122', 'spread': '0.0881', 'groupId': 'OG001'}]}]}, {'title': 'Dim High Contrast', 'categories': [{'measurements': [{'value': '0.086', 'spread': '0.0874', 'groupId': 'OG000'}, {'value': '0.089', 'spread': '0.0846', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-week Follow-up', 'description': 'Distance Visual Acuity (LogMAR) was assessed using an ETDRS chart at the 2-week follow-up for each subject and eye for 2 conditions, Bright low contrast and Dim high contrast. The average visual acuity (LogMAR) for each condition and lens was reported.', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Subjects that completed all study visits without a major protocol deviation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Senofilcon A(Test)/Senofilcon A(Control)', 'description': 'Subjects that were randomized to receive the test lens senofilcon A lens first and then the control lens senofilcon A lens second.'}, {'id': 'FG001', 'title': 'Senofilcon A(Control)/Senofilcon A(Test)', 'description': 'Subjects that were randomized to receive the control lens senofilcon A first and then the test lens senofilcon A lens second.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Unsatisfactory Visual Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Torn Contact Len', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost Contact Lens', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Torn Contact Lens', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 142 subjects were enrolled into this study. Of the enrolled 1 subject did not meet the eligibility criteria and 141 were dispensed a study lens. Of the dispensed subjects 125 completed the study and 16 subjects were discontinued.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dispensed Subjects', 'description': 'All subjects that were dispensed at least one study lens.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.0', 'spread': '8.96', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '98', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '141', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All subjects that were dispensed at least 1 study lens.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-15', 'studyFirstSubmitDate': '2016-03-01', 'resultsFirstSubmitDate': '2017-05-04', 'studyFirstSubmitQcDate': '2016-03-01', 'lastUpdatePostDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-04', 'studyFirstPostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contact Lens Wearing Time', 'timeFrame': '2-week follow-up', 'description': 'Contact lens wearing time was collected for each subject at the 2-week follow-up evaluation. The average contact lens wearing time in hours was reported for each lens.'}, {'measure': 'Visual Acuity (LogMAR)', 'timeFrame': '2-week Follow-up', 'description': 'Distance Visual Acuity (LogMAR) was assessed using an ETDRS chart at the 2-week follow-up for each subject and eye for 2 conditions, Bright low contrast and Dim high contrast. The average visual acuity (LogMAR) for each condition and lens was reported.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Visual Acuity']}, 'descriptionModule': {'briefSummary': 'This is a 4-week, randomized, double-masked study where subjects will wear bilaterally test and control lenses in random succession. The objective is to evaluate materials from different suppliers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.\n2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.\n3. The subject must be at least 18 and not more than 70 years of age (including 70).\n4. The subject's refractive cylinder must be \\< 0.75 Diopters (D) in each eye.\n5. The subject must have best corrected visual acuity of 20/25 or better in each eye.\n6. The subject must be a habitual and adapted wearer of ACUVUE® OASYS® brand contact lens in both eyes (at least 1 month of daily wear).\n7. The subject must have normal eyes (i.e., no ocular medications or infections of any type).\n8. The subject's required spherical contact lens prescription must be in the range of -1.00 D to -6.00 D in each eye.\n\nExclusion Criteria:\n\n1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).\n2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.\n3. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.\n4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia.\n5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)\n6. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.\n7. Any known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens Solution.\n8. Any ocular infection.\n9. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.\n10. Monovision or multi-focal contact lens correction.\n11. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.\n12. History of binocular vision abnormality or strabismus.\n13. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).\n14. Suspicion of or recent history of alcohol or substance abuse.\n15. History of serious mental illness.\n16. History of seizures.\n17. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)"}, 'identificationModule': {'nctId': 'NCT02699593', 'briefTitle': 'Clinical Evaluation of Approved Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'orgStudyIdInfo': {'id': 'CR-5809'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test / Control Sequence', 'description': 'Subjects will be dispensed the Test Contact Lens to wear for two weeks, to be worn in a daily wear modality, attending a follow-up visit in 12-17 days. At the follow-up visit, subjects will be dispensed the Control Contact Lens to wear for two weeks, to be worn in a daily wear modality.', 'interventionNames': ['Device: Test Contact Lens', 'Device: Control Contact Lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control / Test Sequence', 'description': 'Subjects will be dispensed the Control Contact Lens to wear for two weeks, to be worn in a daily wear modality, attending a follow-up visit in 12-17 days. At the follow-up visit, subjects will be dispensed the Test Contact Lens to wear for two weeks, to be worn in a daily wear modality.', 'interventionNames': ['Device: Test Contact Lens', 'Device: Control Contact Lens']}], 'interventions': [{'name': 'Test Contact Lens', 'type': 'DEVICE', 'otherNames': ['senofilcon A made with material from a new supplier'], 'armGroupLabels': ['Control / Test Sequence', 'Test / Control Sequence']}, {'name': 'Control Contact Lens', 'type': 'DEVICE', 'otherNames': ['senofilcon A made with material from the current supplier'], 'armGroupLabels': ['Control / Test Sequence', 'Test / Control Sequence']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Eye Elements Eyecare', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Golden Vision', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'city': 'Neodesha', 'state': 'Kansas', 'country': 'United States', 'facility': 'Advantage Eyecare Associates, LLC', 'geoPoint': {'lat': 37.41839, 'lon': -95.68026}}, {'city': 'Raytown', 'state': 'Missouri', 'country': 'United States', 'facility': 'Advanced Eyecare, PC', 'geoPoint': {'lat': 39.00862, 'lon': -94.46356}}, {'city': 'Westerville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Professional Vision Care', 'geoPoint': {'lat': 40.12617, 'lon': -82.92907}}, {'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Timothy R. Poling, OD', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}