Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-01-05 @ 10:01 AM
Study NCT ID:
NCT02147093
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2014-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TKarkkai@its.jnj.com', 'phone': '904-443-3500', 'title': 'Tom Karkkainen, OD, MS, FAAO', 'phoneExt': '3402', 'organization': 'Johnson & Johnson Vision Care INC.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Throughout duration of the study(approximately 4 months).', 'eventGroups': [{'id': 'EG000', 'title': 'Control (Filcon II 3-sphere)', 'description': 'Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Test (Filcon II 3-multi-focal)', 'description': 'Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Distance LogMAR Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Filcon II 3-sphere)', 'description': 'Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.'}, {'id': 'OG001', 'title': 'Test (Filcon II 3-multi-focal)', 'description': 'Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.'}], 'classes': [{'title': 'High Contrast-Distance-Standard High Luminance', 'categories': [{'measurements': [{'value': '-0.466', 'spread': '0.9995', 'groupId': 'OG000'}, {'value': '-0.972', 'spread': '1.0104', 'groupId': 'OG001'}]}]}, {'title': 'Low Contrast-Distance-Standard High Luminance', 'categories': [{'measurements': [{'value': '-2.842', 'spread': '1.6850', 'groupId': 'OG000'}, {'value': '-3.768', 'spread': '1.8023', 'groupId': 'OG001'}]}]}, {'title': 'High Contrast-Distance-Standard Low Luminance', 'categories': [{'measurements': [{'value': '-2.834', 'spread': '1.0042', 'groupId': 'OG000'}, {'value': '-3.700', 'spread': '0.8939', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days post wear', 'description': 'Distance time controlled LogMAR (Logarithm of the Minimum Angle of Resolution) Visual Acuity was carried out binocularly, at 4m (meter) under 250 cd/m\\^2 and 2.5 cd/m\\^2 (candela per square meter) luminance. The test was presented under the two conditions; High luminance (250 cd/m\\^2) High Contrast (90%) \\& Low Contrast (10%) and Low Luminance (2.5 cd/m\\^2) High Contrast (90%)', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects that completed all study visits without a major protocol deviation.'}, {'type': 'PRIMARY', 'title': 'Near LogMAR Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Filcon II 3-sphere)', 'description': 'Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.'}, {'id': 'OG001', 'title': 'Test (Filcon II 3-multi-focal)', 'description': 'Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.'}], 'classes': [{'title': 'High Contrast-Near-Standard High Luminance', 'categories': [{'measurements': [{'value': '-1.455', 'spread': '0.6309', 'groupId': 'OG000'}, {'value': '-2.545', 'spread': '1.1240', 'groupId': 'OG001'}]}]}, {'title': 'Low Contrast-Near-Standard High Luminance', 'categories': [{'measurements': [{'value': '-2.151', 'spread': '1.0221', 'groupId': 'OG000'}, {'value': '-3.820', 'spread': '1.4124', 'groupId': 'OG001'}]}]}, {'title': 'High Contrast-Near-Standard Low Luminance', 'categories': [{'measurements': [{'value': '-1.878', 'spread': '1.0546', 'groupId': 'OG000'}, {'value': '-3.441', 'spread': '1.3941', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days post wear', 'description': 'Near time controlled LogMAR Visual Acuity was carried out binocularly, at 4cm under 250 cd/m\\^2 and 50 cd/m\\^2 luminance. The test was presented on under the two conditions; High Luminance (250cd/m\\^2) High Contrast (90%) \\& Low Contrast (10%) and Low Luminance (50cd/m\\^2) High Contrast (90%)', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects that completed all study visits without a major protocol deviation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control (Filcon II 3- Sphere) /Test (Filcon II 3-multi-focal)', 'description': 'Subjects were first fitted with the Control lens (filcon II 3- sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (filcon II 3-multi-focal) for one week.'}, {'id': 'FG001', 'title': 'Test (Filcon II 3-multi-focal) /Control (Filcon II 3- Sphere)', 'description': 'Subjects were first fitted with the Test lens (filcon II 3-multi-focal) for one week. Subjects were then fitted with Control lens (filcon II 3- sphere) and a pair of reading glasses for one week.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 41 subjects were enrolled in this study. Of the enrolled subjects 1 did not meet the eligibility criteria and 40 subjects were dispensed a study lens. Of the dispensed subjects, 3 were discontinued and 37 subjects completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control (Filcon II 3-sphere) /Test (Filcon II 3-multi-focal)', 'description': 'All subjects that were randomized to sequence and were dispensed a study lens.'}, {'id': 'BG001', 'title': 'Test (Filcon II 3-multi-focal) / Control (Filcon II 3-spher)', 'description': 'All subjects that were randomized to sequence and were dispensed a study lens.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.20', 'spread': '7.682', 'groupId': 'BG000'}, {'value': '58.00', 'spread': '9.067', 'groupId': 'BG001'}, {'value': '56.78', 'spread': '8.490', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All subjects that were randomized to one of two lens wear serquences.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2014-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2014-05-21', 'resultsFirstSubmitDate': '2015-09-22', 'studyFirstSubmitQcDate': '2014-05-21', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-06-10', 'studyFirstPostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance LogMAR Visual Acuity', 'timeFrame': '7 days post wear', 'description': 'Distance time controlled LogMAR (Logarithm of the Minimum Angle of Resolution) Visual Acuity was carried out binocularly, at 4m (meter) under 250 cd/m\\^2 and 2.5 cd/m\\^2 (candela per square meter) luminance. The test was presented under the two conditions; High luminance (250 cd/m\\^2) High Contrast (90%) \\& Low Contrast (10%) and Low Luminance (2.5 cd/m\\^2) High Contrast (90%)'}, {'measure': 'Near LogMAR Visual Acuity', 'timeFrame': '7 days post wear', 'description': 'Near time controlled LogMAR Visual Acuity was carried out binocularly, at 4cm under 250 cd/m\\^2 and 50 cd/m\\^2 luminance. The test was presented on under the two conditions; High Luminance (250cd/m\\^2) High Contrast (90%) \\& Low Contrast (10%) and Low Luminance (50cd/m\\^2) High Contrast (90%)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Presbyopia Correction']}, 'descriptionModule': {'briefSummary': 'A comparative evaluation of a newly marketed multifocal contact lens with a single vision contact lens when used with near vision spectacles. The evaluation was to quantify the difference between the two test corrections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 45 years or more\n2. Spectacle or soft contact lens wearer\n3. Refraction: best sphere (corrected for back vertex distance) -6.00 Diopters (D) to +4.00 D; Astigmatism - 0.00 D to -0.75 D; Near addition for 40 cm; Medium Add: +1.50 D to +2.00 D; High Add: +2.25 D to +2.50 D\n4. Best spectacle corrected visual acuity of 6/9 or better in each eye\n5. Willingness to adhere to the instructions set forth in the clinical protocol\n6. Signature of the subject Informed Consent form after review of Information to Participant document.\n\nExclusion Criteria:\n\n1. Systemic or ocular allergies which might interfere with contact lens wear\n2. Systemic disease which might interfere with contact lens wear\n3. Ocular disease which might interfere with contact lens wear (e.g. hypothesia, insufficient lacrimal secretion)\n4. Use of medication which might interfere with contact lens wear\n5. Active ocular infection\n6. Use of ocular medication\n7. Significant ocular anomaly\n8. Presence of two or more corneal scars in either eye\n9. Monovision contact lens wearers\n10. Pregnancy or lactation\n11. Any medical condition that might be prejudicial to the study\n12. Participants non-able to give consent or from a vulnerable group\n13. Infectious disease (for example, hepatitis, tuberculosis, etc.) or a contagious immunosuppressive disease (such as HIV, AIDS, etc.)\n14. Employees or family member of the investigational clinic (e.g. investigator, coordinator, technician)'}, 'identificationModule': {'nctId': 'NCT02147093', 'briefTitle': 'CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'orgStudyIdInfo': {'id': 'CR-5175'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control (sphere) /Test (multi-focal)', 'description': 'Subjects were first fitted with Control lens (sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (multi-focal) for one week.', 'interventionNames': ['Device: Test (multi-focal)', 'Device: Control (Sphere)']}, {'type': 'OTHER', 'label': 'Test (sphere) /Control (multi-focal)', 'description': 'Subjects were first fitted with the Test lens (multi-focal) for one week. Subjects were then fitted with Control lens (sphere) and a pair of reading glasses for one week.', 'interventionNames': ['Device: Test (multi-focal)', 'Device: Control (Sphere)']}], 'interventions': [{'name': 'Test (multi-focal)', 'type': 'DEVICE', 'otherNames': ['Clariti 1 Day', 'filcon II 3'], 'description': 'contact lens was to be worn a daily wear.', 'armGroupLabels': ['Control (sphere) /Test (multi-focal)', 'Test (sphere) /Control (multi-focal)']}, {'name': 'Control (Sphere)', 'type': 'DEVICE', 'otherNames': ['filcon II 3'], 'description': 'contact lens was to be worn a daily wear with spectacles', 'armGroupLabels': ['Control (sphere) /Test (multi-focal)', 'Test (sphere) /Control (multi-focal)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW1E6AU', 'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}