Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-01-03 @ 9:09 PM
Study NCT ID:
NCT02669095
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2016-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical 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': 'Johnson & Johnson Vision Care Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Senofilcon C', 'description': 'Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.', 'otherNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Comfilcon A', 'description': 'Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.', 'otherNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acceptable Lens Fitting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}, {'units': 'Subject Eyes', 'counts': [{'value': '740', 'groupId': 'OG000'}, {'value': '720', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon C', 'description': 'Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0.99', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 Week Follow-up', 'description': 'Lens fit was assessed and recorded for each subject and eye at post lens fitting, 1-, 2-, 3- and 4- week follow-up evaluations. Lens fit was a binary response acceptable and unacceptable lens fit. The proportion of eyes with acceptable lens fitting at post lens fit and across all four follow-ups was combined and reported.', 'unitOfMeasure': 'Proportion of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Subject Eyes', 'denomUnitsSelected': 'Subject Eyes', 'populationDescription': 'Subjects that completed all study visits without a major protocol deviation.'}, {'type': 'PRIMARY', 'title': 'Overall Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon C', 'description': 'Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.'}, {'id': 'OG001', 'title': 'Comfilcon A', 'description': 'Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.'}], 'classes': [{'title': '1-Week Follow-up', 'categories': [{'measurements': [{'value': '71.75', 'spread': '22.193', 'groupId': 'OG000'}, {'value': '56.68', 'spread': '27.747', 'groupId': 'OG001'}]}]}, {'title': '2-Week Follow-up', 'categories': [{'measurements': [{'value': '70.58', 'spread': '22.500', 'groupId': 'OG000'}, {'value': '54.69', 'spread': '30.268', 'groupId': 'OG001'}]}]}, {'title': '3-Week Follow-up', 'categories': [{'measurements': [{'value': '68.75', 'spread': '26.108', 'groupId': 'OG000'}, {'value': '53.43', 'spread': '29.912', 'groupId': 'OG001'}]}]}, {'title': '4-Week Follow-up', 'categories': [{'measurements': [{'value': '68.25', 'spread': '27.137', 'groupId': 'OG000'}, {'value': '54.57', 'spread': '30.522', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 Week Follow-up', 'description': 'Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. CLUE Comfort was assessed at 1-, 2-, 3 and 4- week Follow-up evaluations. The average CLUE comfort score for each lens was reported for each visit.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects that completed all study visits without a major protocol deviation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Senofilcon C', 'description': 'Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.'}, {'id': 'FG001', 'title': 'Comfilcon A', 'description': 'Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory Lens Fitting', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Torn Lens', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Visit 5 assessments not completed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 150 subjects were enrolled in this study. All subjects enrolled into the study were dispensed a study lens. Of the dispensed subjects 146 completed the study and 4 subjects were discontinued.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Senofilcon C', 'description': 'Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.'}, {'id': 'BG001', 'title': 'Comfilcon A', 'description': 'Subjects that were randomized to receive 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': '28.2', 'spread': '6.05', 'groupId': 'BG000'}, {'value': '30.2', 'spread': '5.62', 'groupId': 'BG001'}, {'value': '29.2', 'spread': '5.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All subjects that were dispensed a study lens.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2016-01-27', 'resultsFirstSubmitDate': '2017-03-17', 'studyFirstSubmitQcDate': '2016-01-28', 'lastUpdatePostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-04', 'studyFirstPostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptable Lens Fitting', 'timeFrame': 'Up to 4 Week Follow-up', 'description': 'Lens fit was assessed and recorded for each subject and eye at post lens fitting, 1-, 2-, 3- and 4- week follow-up evaluations. Lens fit was a binary response acceptable and unacceptable lens fit. The proportion of eyes with acceptable lens fitting at post lens fit and across all four follow-ups was combined and reported.'}, {'measure': 'Overall Comfort', 'timeFrame': 'Up to 4 Week Follow-up', 'description': 'Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. CLUE Comfort was assessed at 1-, 2-, 3 and 4- week Follow-up evaluations. The average CLUE comfort score for each lens was reported for each visit.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Visual Disorder']}, 'descriptionModule': {'briefSummary': 'This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design, double-masked clinical trial using an investigational contact lens and a marketed contact lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear modality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', '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 between 18 to 40 years of age at the time of consent.\n* The subject's vertexed spherical equivalent distance refraction must be in the range of +8.00 to -12.00 in each eye.\n* Subject wears habitual contact lenses a minimum of 4 days per week, eight hours per day.\n* The subject must have best corrected visual acuity of 20/30 or better in each eye.\n* The subject must be a habitual frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.\n* The subject must be able to wear contact lenses for a minimum of 8 hours each day during the study.\n* The subject must have normal eyes (i.e., no ocular medications or infections of any type).\n\nExclusion Criteria:\n\n* Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).\n* Any ocular or systemic allergies or diseases that may interfere with contact lens wear.\n* Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.\n* Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.\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 ocular infection.\n* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.\n* Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment."}, 'identificationModule': {'nctId': 'NCT02669095', 'briefTitle': 'Clinical Evaluation of Approved and Investigational Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'orgStudyIdInfo': {'id': 'CR-5796'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 (Test Lens)', 'description': 'Subjects will be dispensed the Investigational Contact Lenses (Test) to be worn as daily wear.', 'interventionNames': ['Device: Investigational Contact Lenses (Test)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2 (Control Lens)', 'description': 'Subjects will be dispensed the Marketed Contact Lenses (Control) to be worn as daily wear.', 'interventionNames': ['Device: Marketed Contact Lenses (Control)']}], 'interventions': [{'name': 'Investigational Contact Lenses (Test)', 'type': 'DEVICE', 'otherNames': ['senofilcon C'], 'armGroupLabels': ['Arm 1 (Test Lens)']}, {'name': 'Marketed Contact Lenses (Control)', 'type': 'DEVICE', 'otherNames': ['comfilcon A'], 'armGroupLabels': ['Arm 2 (Control Lens)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Golden Family Eyecare', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '32792', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Eye Associates of Winter Park', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '29671', 'city': 'Pickens', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Pickens Family Eye Care', 'geoPoint': {'lat': 34.88345, 'lon': -82.70736}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Total Eye Care PA', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}