Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-05 @ 3:30 AM
Study NCT ID:
NCT02625233
Status:
COMPLETED
Last Update Posted:
2017-06-19
First Post:
2015-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Long-Term Evaluation of Approved and Investigational Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'KCANAVA2@its.jnj.com', 'phone': '904 443-1474', 'title': 'Kristy Canavan, O.D., FAAO Principal Research Optometrist', 'organization': 'Johson & Johnson Vision Care Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Throught the duration of the study. Approximately 3 months per subject.', 'description': 'NCT02625233 is a continuation of NCT02515994. Each study was approximately 3 months duration for each subject(i.e. if a subject was enrolled into both studies they wore the lens a total of 6 months). Refer to the adverse event information for study NCT02515994 for the previous 3 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Senofilcon C', 'description': 'Subjects that wore the senofilcon C lens throughout the entire duration of the study.', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Comfilcon A', 'description': 'Subjects that wore the comfilcon A lens throughout the entire duration of the study.', 'otherNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Eyes Grade 3 or Higher SLF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}, {'units': 'Subject Eyes', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon C', 'description': 'Subjects that wore the senofilcon C lens througout the entire duration of the study.'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects that wore the comfilcon A lens throughout the entire duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 Month Follow-up', 'description': 'Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The proportion of subject eyes with SLF grade 3 or higher was reported for each lens.', 'unitOfMeasure': 'Proporiton of Subject Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Subject Eyes', 'denomUnitsSelected': 'Subject Eyes', 'populationDescription': 'Subjects that were dispensed a study lens.'}, {'type': 'PRIMARY', 'title': 'Visual Acuity (logMAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}, {'units': 'Subject Eyes', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon C', 'description': 'Subjects that wore the senofilcon C lens througout the entire duration of the study.'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects that wore the comfilcon A lens throughout the entire duration of the study.'}], 'classes': [{'title': 'Overall N=376, N=448', 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.066', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.074', 'groupId': 'OG001'}]}]}, {'title': 'Initial Visit N=94, N=112', 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.069', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.064', 'groupId': 'OG001'}]}]}, {'title': '4 Month Follow-up N=94, N=112', 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.069', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.075', 'groupId': 'OG001'}]}]}, {'title': '5 Month Follow-up N=94, N=112', 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.068', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.078', 'groupId': 'OG001'}]}]}, {'title': '6 Month Follow-up N=94, N=112', 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.063', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.072', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 Month Follow-up', 'description': 'The visual acuity (LogMAR) was collected at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The average Visual Acuity (logMAR) across the 4 study visits and at each individual visit was reported for each lens.', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Subject Eyes', 'denomUnitsSelected': 'Subject Eyes', 'populationDescription': 'Subjects that completed all study visits.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Senofilcon C', 'description': 'Subjects that wore the senofilcon C lens throughout the entire duration of the study.'}, {'id': 'FG001', 'title': 'Comfilcon A', 'description': 'Subjects that wore the comfilcon A lens throughout the entire duration of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 105 subjects were enrolled into this study. Of the enrolled subjects all were dispensed a study lens. Out of all the dispensed subjects 103 completed the study while 2 subjects were discontinued.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Senofilcon C', 'description': 'Subjects that wore the senofilcon C lens throughout the entire duration of the study.'}, {'id': 'BG001', 'title': 'Comfilcon A', 'description': 'Subjects that wore the comfilcon A lens throughout the entire duration of the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.2', 'spread': '7.03', 'groupId': 'BG000'}, {'value': '31.5', 'spread': '7.31', 'groupId': 'BG001'}, {'value': '31.4', 'spread': '7.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All subjects that were enrolled into the study.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-19', 'studyFirstSubmitDate': '2015-11-03', 'resultsFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2015-12-04', 'lastUpdatePostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-19', 'studyFirstPostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Eyes Grade 3 or Higher SLF', 'timeFrame': 'Up to 6 Month Follow-up', 'description': 'Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The proportion of subject eyes with SLF grade 3 or higher was reported for each lens.'}, {'measure': 'Visual Acuity (logMAR)', 'timeFrame': 'Up to 6 Month Follow-up', 'description': 'The visual acuity (LogMAR) was collected at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The average Visual Acuity (logMAR) across the 4 study visits and at each individual visit was reported for each lens.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Visual Disorders']}, 'descriptionModule': {'briefSummary': 'This is a multi-site, dispensing, 4-visit, 2-arm parallel group, randomized, double-masked clinical trial using a Vistakon investigational contact lens (test) and a marketed monthly replacement contact lens (control). Each subject will be assigned randomly to either the test or control lens to evaluate the long term safety and efficacy of the investigational contact lens compared to the marketed contact lens over a period of six months of lens wear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.\n* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.\n* The subject must be at least 18 years of age.\n* The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye.\n* The subject's refractive cylinder must be ≤ 1.00 Diopters (D) in each eye.\n* The subject must have best corrected visual acuity of 20/25 or better in each eye.\n* The subject should own a wearable pair of spectacles and bring to initial visit.\n* The subject must be an adapted frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.\n* The subject must have normal eyes (i.e., no ocular medications or infections of any type).\n* The subject must have enrolled and completed all visits in clinical study (NCT02515994).\n\nExclusion Criteria:\n\n* Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).\n* Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g., hepatitis, tuberculosis).\n* Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g., Accutane), oral tetracyclines, topical scopolamine, oral phenothiazines (e.g. Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or OTC ocular medication.\n* Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.\n* Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)\n* 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.\n* Any known hypersensitivity or allergic reaction to Opti-Free® PureMoist® multipurpose care solution or Eye-Cept rewetting drop solution\n* Any ocular infection, allergy or clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study.\n* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.\n* Daily disposables, extended wear, monovision or multi-focal contact lens correction.\n* History of binocular vision abnormality or strabismus.\n* Employee or relative of employees of sponsor or investigational clinic (e.g., Investigator, Coordinator, Technician)"}, 'identificationModule': {'nctId': 'NCT02625233', 'briefTitle': 'Clinical Long-Term Evaluation of Approved and Investigational Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'orgStudyIdInfo': {'id': 'CR-5788'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'senofilcon C', 'description': 'Vistakon Investigational Contact Lens (Test)', 'interventionNames': ['Device: senofilcon C']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'comfilcon A', 'description': 'Marketed Monthly Wear Contact Lens (Control)', 'interventionNames': ['Device: comfilcon A']}], 'interventions': [{'name': 'senofilcon C', 'type': 'DEVICE', 'armGroupLabels': ['senofilcon C']}, {'name': 'comfilcon A', 'type': 'DEVICE', 'armGroupLabels': ['comfilcon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32205', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Vue Optical Boutique', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32779', 'city': 'Longwood', 'state': 'Florida', 'country': 'United States', 'facility': 'Omega Vision Center, PA / Sabal Eye Care', 'geoPoint': {'lat': 28.70305, 'lon': -81.3384}}, {'zip': '61701', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'facility': 'Eyecare Associates', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '07624', 'city': 'Closter', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Dr. Debbie H. Kim, OD', 'geoPoint': {'lat': 40.97315, 'lon': -73.96153}}, {'zip': '13850', 'city': 'Vestal', 'state': 'New York', 'country': 'United States', 'facility': 'Sacco Eye Group', 'geoPoint': {'lat': 42.08507, 'lon': -76.05381}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Dr. William Bogus', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}