Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 11:04 PM
Study NCT ID:
NCT05344560
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2022-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Toric Soft Contact Lenses Containing a Chromophore to Block High-Energy Visible Light
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D003263', 'term': 'Contact Lenses, Hydrophilic'}], 'ancestors': [{'id': 'D003261', 'term': 'Contact Lenses'}, {'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bstraker@its.jnj.com', 'phone': '1-800-843-2020', 'title': 'Benjamin Straker', 'organization': 'Johnson & Johnson Vision Care, Inc. (JJVC)'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Throughout the duration of the study; Approximately 3-weeks per subject.', 'eventGroups': [{'id': 'EG000', 'title': 'Test [Senofilcon A (C3) HEV Chromophore]', 'description': 'Subjects that wore the Test \\[senofilcon A (C3) HEV chromophore\\] lens during any point in the study.', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 0, 'seriousNumAtRisk': 125, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control [Senofilcon A (C3)]', 'description': 'Subjects that wore the Control \\[senofilcon A (C3)\\] lens during any point in the study.', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 0, 'seriousNumAtRisk': 125, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CLUE Comfort Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test [Senofilcon A (C3) HEV Chromophore]', 'description': 'Subjects that wore the Test \\[senofilcon A (C3) HEV chromophore\\] lens during any of the three study periods.'}, {'id': 'OG001', 'title': 'Control [Senofilcon A (C3)]', 'description': 'Subjects that wore the Control \\[senofilcon A (C3)\\] lens during any of the three study periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.50', 'spread': '19.581', 'groupId': 'OG000'}, {'value': '65.28', 'spread': '20.915', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.92', 'ciLowerLimit': '-6.92', 'ciUpperLimit': '1.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.018', 'estimateComment': 'Mean difference was calculated as Test \\[senofilcon A (C3) HEV chromophore\\] minus Control \\[senofilcon A (C3)\\]', 'statisticalMethod': 'Generalized Linear Mixed Model', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Kenward and Roger Method was used for the denominator degrees of freedom.', 'nonInferiorityComment': 'A non-inferiority margin of -5 points was used.'}], 'paramType': 'MEAN', 'timeFrame': '1-Week Follow-up', 'description': 'Subjective comfort was assessed using Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (Comfort, Vision, Handling, and Packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution where scores range from 0 to 120 with a population average score of 60 (SD 20). Higher CLUE scores indicate a more favorable/positive response. The average CLUE comfort score was report for each lens type.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test\\Control\\Control', 'description': 'Subjects in this sequence were randomized to receive the Test \\[senofilcon A (C3) HEV chromophore\\] lens during the first period and the Control \\[senofilcon A (C3)\\] lens during the second and third periods .'}, {'id': 'FG001', 'title': 'Control\\Test\\Test', 'description': 'Subjects in this sequence were randomized to receive the Control \\[senofilcon A (C3)\\] lens during the first period and the Test \\[senofilcon A (C3) HEV chromophore\\] lens during the second and third periods.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Subject out of visit window', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Covid-19 Related', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subject out of visit window', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Subject out of visit window', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 126 subjects were enrolled in this study. Of those enrolled, all 126 subjects were dispensed at least one study lens. Of those dispensed, 119 subjects completed the study while 7 subjects were discontinued.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dispensed Subjects', 'description': 'All subjects dispensed at least one study lens.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'spread': '5.86', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '11', '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': 'United States', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All subjects dispensed at least one study lens.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-14', 'size': 1221744, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-04T01:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-11', 'studyFirstSubmitDate': '2022-04-19', 'resultsFirstSubmitDate': '2023-08-04', 'studyFirstSubmitQcDate': '2022-04-19', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-11', 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CLUE Comfort Score', 'timeFrame': '1-Week Follow-up', 'description': 'Subjective comfort was assessed using Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (Comfort, Vision, Handling, and Packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution where scores range from 0 to 120 with a population average score of 60 (SD 20). Higher CLUE scores indicate a more favorable/positive response. The average CLUE comfort score was report for each lens type.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Visual Acuity']}, 'descriptionModule': {'briefSummary': 'This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treament, 2-sequence, 3-period crossover study to evalulate overall vision and comfort..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPotential subjects must satisfy of all the following criteria to be enrolled in the study.\n\n1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.\n2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.\n3. Be between 18 and 39 years of age (inclusive) at the time of screening.\n4. By self-report, habitually wear soft contact lenses in both eyes in a daily or daily disposable wear modality (i.e. not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past four weeks.\n5. Possess a wearable pair of spectacles that provide correction for distance vision.\n6. In both eyes, have refractive error suitable for correction with the toric contact lens powers available in this study:\n\n 1. Sphere powers (DS) -1.50 through -4.00 in 0.25 steps\n 2. Cylinder powers (DC) -0.75 and -1.25\n 3. Axes (degrees) 170, 180, 10, 80, 90, 100\n7. Have best corrected monocular distance visual acuity of 20/30 or better in each eye.\n\nExclusion Criteria:\n\nPotential subjects who meet any of the following criteria will be excluded from participating in the study:\n\n1. Be currently pregnant or lactating.\n2. Be diabetic.\n3. Be currently using any ocular medications or have an ocular infection of any type.\n4. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \\[HIV\\]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures.\n5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.\n6. Be currently wearing monovision or multifocal contact lenses.\n7. Be currently wearing lenses in an extended wear modality.\n8. Have a history of strabismus or amblyopia.\n9. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.\n10. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment."}, 'identificationModule': {'nctId': 'NCT05344560', 'briefTitle': 'Evaluation of Toric Soft Contact Lenses Containing a Chromophore to Block High-Energy Visible Light', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'officialTitle': 'Evaluation of Toric Soft Contact Lenses Containing a Chromophore to Block High-Energy Visible Light Produced on Commercial Manufacturing Lines', 'orgStudyIdInfo': {'id': 'CR-6484'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'test/control/control', 'description': 'Eligible subjects that are habitual contact lens wearers will be randomized into the (test/control/control) sequence and will wear two different study lenses one at a time bilaterally over three wear periods.', 'interventionNames': ['Device: soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore', 'Device: ACUVUE OASYS 1-Day for Astigmatism']}, {'type': 'EXPERIMENTAL', 'label': 'control/test/test', 'description': 'Eligible subjects that are habitual contact lens wearers will be randomized into the (control/test/test) sequence and will wear two different study lenses one at a time bilaterally over three wear periods.', 'interventionNames': ['Device: soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore', 'Device: ACUVUE OASYS 1-Day for Astigmatism']}], 'interventions': [{'name': 'soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore', 'type': 'DEVICE', 'description': 'TEST Lens', 'armGroupLabels': ['control/test/test', 'test/control/control']}, {'name': 'ACUVUE OASYS 1-Day for Astigmatism', 'type': 'DEVICE', 'description': 'CONTROL Lens', 'armGroupLabels': ['control/test/test', 'test/control/control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32218', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Dr. James Weber & Associates, PA - City Square Blvd', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Stam & Associates Eye Care', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32779', 'city': 'Longwood', 'state': 'Florida', 'country': 'United States', 'facility': 'Sabal Eye Care', 'geoPoint': {'lat': 28.70305, 'lon': -81.3384}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Maitland Vision Center - North Orlando Ave', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '32819', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Southwest Orlando Eye Care', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '66762', 'city': 'Pittsburg', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kannarr Eye Care', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'zip': '43023', 'city': 'Granville', 'state': 'Ohio', 'country': 'United States', 'facility': 'ProCare Vision Centers', 'geoPoint': {'lat': 40.06812, 'lon': -82.5196}}, {'zip': '02888', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Dr. David W. Ferris & Associates', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '38111', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Optometry Group, LLC', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75703', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Tyler Eye Associates', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}], 'overallOfficials': [{'name': 'Johnson & Johnson Vision Care, Inc. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson Vision Care, Inc.'}]}, 'ipdSharingStatementModule': {'url': 'http://yoda.yale.edu', 'ipdSharing': 'YES', 'description': 'Johnson \\& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}