Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-25 @ 5:37 AM
Study NCT ID:
NCT02345720
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2015-01-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Multifocal Contact Lens on Ocular Tissue
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 the duration of the study. Approximately 3 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Etafilcon PVP (Multi-focal)', 'description': 'All subjects wore the same study lenses throughout the duration of this study.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Upper Eye Lid Margin Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etafilcon PVP (Multi-focal)', 'description': 'All subjects wore the same study lenses throughout the duration of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.96', 'spread': '1.03', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days Post wear', 'description': 'Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm\\^2.', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of all subjects that were dispensed a study lens.'}, {'type': 'PRIMARY', 'title': 'Limbal Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etafilcon PVP (Multi-focal)', 'description': 'All subjects wore the same study lenses throughout the duration of this study.'}], 'classes': [{'title': 'Nasal', 'categories': [{'measurements': [{'value': '1.03', 'spread': '1.30', 'groupId': 'OG000'}]}]}, {'title': 'Temporal', 'categories': [{'measurements': [{'value': '0.68', 'spread': '1.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 Days Post Wear', 'description': 'Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.', 'unitOfMeasure': 'percentage of limbal area', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consist of all subjects that were dispensed a study lens.'}, {'type': 'PRIMARY', 'title': 'Corneal Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etafilcon PVP (Multi-focal)', 'description': 'All subjects wore the same study lenses throughout the duration of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 Days Post Wear', 'description': 'The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.', 'unitOfMeasure': 'percentage of upper corneal quadrant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of all subjects that were dispensed a study lens.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etafilcon PVP (Multi-focal)', 'description': 'All subjects wore the same study lenses throughout the duration of this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 23 subjects were enrolled in this study. Of the enrolled subjects, 3 did not meet the eligibility criteria and 20 were dispensed a study lens. All dispensed subjects completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Etafilcon PVP (Multi-focal)', 'description': 'All subjects wore the same study lenses throughout the duration of this study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.6', 'spread': '6.85', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All subjects that were dispensed a study lens.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2015-01-19', 'resultsFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2015-01-23', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-11', 'studyFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper Eye Lid Margin Staining', 'timeFrame': '30 days Post wear', 'description': 'Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm\\^2.'}, {'measure': 'Limbal Staining', 'timeFrame': '30 Days Post Wear', 'description': 'Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.'}, {'measure': 'Corneal Staining', 'timeFrame': '30 Days Post Wear', 'description': 'The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Visual Acuity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the etafilcon - PVP (multi-focal)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 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 between 40 and 70 years of age.\n4. The subject\'s vertex corrected spherical equivalent distance refraction must be in the range of 1.00 too -5.75 in each eye.\n5. The subject must identify themselves as Asian by self-report and have eyes and eyelids with an automatically Asian appearance.\n6. The subject\'s refractive cylinder must be less than or equal to -0.75D in each eye.\n7. The subject\'s ADD power must be in the range of +0.75 D to +2.5 D in each eye.\n8. The subject must have best corrected visual acuity of 20/20-3 or better in each eye.\n9. Subjects own a wearable pair of spectacles, if required for their distance vision.\n10. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 5 days per week for at least 8 hours per day, for one month or more duration).\n11. The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".\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 that contraindicate contact lens wear.\n3. Any ocular or systemic disease, autoimmune disease, or use of medication, that will contraindicate contact lens wear.\n4. Any ocular abnormality that may interfere with contact lens wear.\n5. Use of any ocular medications, with the exception of rewetting drops.\n6. Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).\n7. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.\n8. History of herpetic keratitis.\n9. Any ocular infection or inflammation.\n10. Any corneal distortion or irregular cornea.\n11. History of binocular vision abnormality or strabismus.\n12. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV).\n13. History of diabetes.\n14. Habitual wearer of etafilcon-A contact lens material.\n15. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.'}, 'identificationModule': {'nctId': 'NCT02345720', 'briefTitle': 'Effects of Multifocal Contact Lens on Ocular Tissue', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'officialTitle': 'Effects on Ocular Tissues of Vistakon® Investigational Multifocal Contact Lenses - Asian Population Study', 'orgStudyIdInfo': {'id': 'CR-5632'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'etafilcon - PVP (multi-focal)', 'description': 'The investigational soft contact lenses will be worn in a daily wear modality for 30 days over the course of the study.', 'interventionNames': ['Device: etafilcon - PVP (multi-focal)']}], 'interventions': [{'name': 'etafilcon - PVP (multi-focal)', 'type': 'DEVICE', 'description': 'The investigational contact lens must be worn at least six hours daily.', 'armGroupLabels': ['etafilcon - PVP (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'}}}}