Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT04093258
Status:
COMPLETED
Last Update Posted:
2021-12-01
First Post:
2019-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Two Silicone Hydrogel Multifocal Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tkarkkai@its.jnj.com', 'phone': '1-800-843-2020', 'title': 'Thomas R. Karkkainen, OD, MS, FAAO', 'organization': 'Johnson & Johnson Vision Care'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Throughout the duration of the study. Approximately 2 weeks per subject', 'description': 'All subjects dispensed at least 1 study lens.', 'eventGroups': [{'id': 'EG000', 'title': 'Test', 'description': 'Subjects that wore the Test lens in either the first or second period of the study.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Subjects that wore the Control lens in either the first or second period of the study.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Subjects that wore the Test lens in either the first or second period of the study.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects that wore the Control lens in either the first or second period of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000'}, {'value': '91.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '0.33', 'ciUpperLimit': '6.85', 'estimateComment': 'Odds ratio was calculated as Test/Control', 'groupDescription': 'The proportion of response ("1") was analyzed using a generalized linear mixed model with a binary distribution and logit link function for all questions.', 'statisticalMethod': 'Generalized Linear Mixed Model Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': "Finite-sample corrected Akaike's Information Criterion", 'nonInferiorityComment': 'Non-inferiority will be concluded if the lower limit is above 0.67. Superiority will be concluded if the lower limit is above 1.0.'}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 days', 'description': 'Lens centration was assessed using a biomicroscope and was graded using the scale (Grade: 0, 1,2) with grade 0 represent Centered, Grade 1 = Slightly Decentered and Grade 2= substantially decentered. The data was then dichotomized into two groups: those with grade 1 or higher and those with grade 0 (centered). The percentage of participants with Grade 0 Lens centration was reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects dispensed at least one study lens.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Lens Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Subjects that wore the Test lens in either the first or second period of the study.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects that wore the Control lens in either the first or second period of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000'}, {'value': '91.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.10', 'ciUpperLimit': '1.19', 'estimateComment': 'Odds ratio was calculated as Test over Control', 'groupDescription': 'The proportion of response ("1") was analyzed using a generalized linear mixed model with a binary distribution and logit link function for all questions.', 'statisticalMethod': 'Generalized Linear Mixed Model Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': "Finite-sample corrected Akaike's Information Criterion", 'nonInferiorityComment': 'Non-inferiority will be concluded if the lower limit is above 0.67. Superiority will be concluded if the lower limit is above 1.0.'}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 days', 'description': 'Lens movement in primary gaze was assessed using a biomicroscope and was graded using the scale (Insufficient/Unacceptable (-2), Minimal/Acceptable (-1), Optimal (0), Moderate/Acceptable (+1) and Excessive/Unacceptable (+2)) with Optimal (0) representing no lens movement. The data was then dichotomized into two groups: those with Optimal Lens movement and otherwise (-2, -1, +1 and +2). The percentage of participants with Optimal Lens movement was reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects dispensed at least one study lens.'}, {'type': 'SECONDARY', 'title': 'Overall Handling Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Subjects that wore the Test lens in either the first or second period of the study.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects that wore the Control lens in either the first or second period of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.3', 'spread': '19.02', 'groupId': 'OG000'}, {'value': '55.3', 'spread': '18.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.98', 'ciLowerLimit': '-12.48', 'ciUpperLimit': '0.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.202', 'estimateComment': 'Mean difference was calculated as Test minus Control', 'statisticalMethod': 'Mixed Model Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.', 'nonInferiorityComment': 'The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.'}], 'paramType': 'MEAN', 'timeFrame': '6 to 8 days', 'description': 'Overall handling 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, aged 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.', 'unitOfMeasure': 'CLUE points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All subjects who had successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test/Control', 'description': 'Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period.'}, {'id': 'FG001', 'title': 'Control/Test', 'description': 'Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Subject no longer meets the eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'In total, 42 subjects were enrolled in this study; of which, 41 were randomly assigned into 2 sequences while, 1 subject failed to meet all eligibility criteria. Of the total assigned subjects, 40 subjects completed the study while, 1 subject was discontinued from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects', 'description': 'All subjects dispensed a study lens.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.2', 'spread': '6.76', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'USA', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All subjects dispensed a study lens.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-19', 'size': 13086184, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-12-10T03:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-29', 'studyFirstSubmitDate': '2019-09-16', 'resultsFirstSubmitDate': '2020-12-10', 'studyFirstSubmitQcDate': '2019-09-16', 'lastUpdatePostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-28', 'studyFirstPostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Lens Centration', 'timeFrame': '6 to 8 days', 'description': 'Lens centration was assessed using a biomicroscope and was graded using the scale (Grade: 0, 1,2) with grade 0 represent Centered, Grade 1 = Slightly Decentered and Grade 2= substantially decentered. The data was then dichotomized into two groups: those with grade 1 or higher and those with grade 0 (centered). The percentage of participants with Grade 0 Lens centration was reported.'}, {'measure': 'Percentage of Participants With Lens Movement', 'timeFrame': '6 to 8 days', 'description': 'Lens movement in primary gaze was assessed using a biomicroscope and was graded using the scale (Insufficient/Unacceptable (-2), Minimal/Acceptable (-1), Optimal (0), Moderate/Acceptable (+1) and Excessive/Unacceptable (+2)) with Optimal (0) representing no lens movement. The data was then dichotomized into two groups: those with Optimal Lens movement and otherwise (-2, -1, +1 and +2). The percentage of participants with Optimal Lens movement was reported.'}], 'secondaryOutcomes': [{'measure': 'Overall Handling Scores', 'timeFrame': '6 to 8 days', 'description': 'Overall handling 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, aged 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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Visual Acuity']}, 'descriptionModule': {'briefSummary': 'This is a single-masked, randomized-controlled, dispensing clinical trial. A total of approximately 40 eligible hyperopic and myopic subjects will be targeted to complete the study. The subjects will be fit in the first study lens and worn for a total of 8-12 days following a 7±3 day wash-out period. The procedures will be repeated for the 2nd lens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Potential subjects must satisfy all the following criteria to be enrolled in the study:\n\n 1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.\n 2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.\n 3. The subject must be between 40 and 70 years of age (inclusive).\n 4. The subject\'s distance spherical equivalent refraction must be in the range of +1.25 D to +3.75 D or -1.25 D to -4.00 D in each eye.\n 5. The subject\'s refractive cylinder must be ≤0.75 D in each eye.\n 6. The subject\'s ADD power must be in the range of +0.75 D to +2.50 D.\n 7. The subject must have best corrected visual acuity of 20/20-3 or better in each eye.\n 8. Subjects must own a wearable pair of spectacles if required for their distance vision.\n 9. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration).\n 10. The subject must either 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\n Exclusion Criteria:\n* Potential subjects who meet any of the following criteria will be excluded from participating in the study:\n\n 1. Currently pregnant or lactating.\n 2. Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.\n 3. Any active or ongoing 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, Sjögren\'s syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).\n 4. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.\n 5. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.\n 6. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy, cataract surgery, retinal surgery, etc.).\n 7. A history of amblyopia, strabismus or binocular vision abnormality.\n 8. Any current ocular infection or inflammation.\n 9. Any current ocular abnormality that may interfere with contact lens wear.\n 10. Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral antihistamines (e.g., Chlor-Trimeton, and Benadryl), systemic steroids.\n 11. Use of any ocular medication, with the exception of rewetting drops.\n 12. History of herpetic keratitis.\n 13. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.\n 14. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).\n 15. Any known hypersensitivity or allergic reaction to OPTI-FREE® Puremoist® multipurpose care solution, sodium fluorescein or single-use preservative free rewetting drop solution.'}, 'identificationModule': {'nctId': 'NCT04093258', 'briefTitle': 'Comparison of Two Silicone Hydrogel Multifocal Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'officialTitle': 'Comparison of Two Silicone Hydrogel Multifocal Contact Lenses', 'orgStudyIdInfo': {'id': 'CR-6344'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test/Control', 'description': 'Eligible subjects between 40-70 years of age who are habitual soft contact lens wearers and hyperopic or myopic and have presbyopia will be randomized to one of two sequences (Test/Control or Control/Test) with a 4-10 day washout period in between each fitting.', 'interventionNames': ['Device: Dailies Total 1® Multifocal Contact Lenses', 'Device: Air Optix® Multifocal Contact Lenses Plus HydraGlyde®']}, {'type': 'EXPERIMENTAL', 'label': 'Control/Test', 'description': 'Eligible subjects between 40-70 years of age who are habitual soft contact lens wearers and hyperopic or myopic and have presbyopia will be randomized to one of two sequences (Test/Control or Control/Test) with a 4-10 day washout period in between each fitting.', 'interventionNames': ['Device: Dailies Total 1® Multifocal Contact Lenses', 'Device: Air Optix® Multifocal Contact Lenses Plus HydraGlyde®']}], 'interventions': [{'name': 'Dailies Total 1® Multifocal Contact Lenses', 'type': 'DEVICE', 'description': 'TEST', 'armGroupLabels': ['Control/Test', 'Test/Control']}, {'name': 'Air Optix® Multifocal Contact Lenses Plus HydraGlyde®', 'type': 'DEVICE', 'description': 'CONTROL', 'armGroupLabels': ['Control/Test', 'Test/Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Visual Eyes', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '43023', 'city': 'Granville', 'state': 'Ohio', 'country': 'United States', 'facility': 'ProCare Vision Centers', 'geoPoint': {'lat': 40.06812, 'lon': -82.5196}}, {'zip': '38111', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Optometry Group, LLC', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, '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'}}}}