Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT04954833
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2021-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluating Visual Acuity and Initial Fit Performance of Two Soft Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'xcheng6@its.jnj.com', 'phone': '1-800-843-2020', 'title': 'Xu Cheng', 'organization': 'Johnson & Johnson Vision Care, Inc. (JJVC)'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Throughout the duration of the study; The study duration for each subject is approximately 3 hours within 1 day.', 'description': 'All subjects dispensed at least 1 study lens.', 'eventGroups': [{'id': 'EG000', 'title': 'Test (EMO-200)', 'description': 'Subjects that wore the Test lens in either the first or second period of the study.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control (EMO-118)', 'description': 'Subjects that wore the Control lens in either the first or second period of the study.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Monocular Distance Visual Acuity (logMAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (EMO-200)', 'description': 'Subjects that wore the Test lens in either the first or second period of the study.'}, {'id': 'OG001', 'title': 'Control (EMO-118)', 'description': 'Subjects that wore the Control lens in either the first or second period of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.144', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.140', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.006', 'estimateComment': 'LS Mean difference was calculated as Test - 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': 'A non-inferiority margin of 0.05 logMAR. A value of 0.05 logMAR is approximately 2.5 letters on the ETDRS chart.'}], 'paramType': 'MEAN', 'timeFrame': '10 minutes post lens insertion', 'description': 'Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by- letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.00 is equivalent to Snellen visual acuity of 20/20.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Subjects that completed all study visits without a major protocol deviation.'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects' Eyes With Acceptable Lens Fit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (EMO-200)', 'description': 'Subjects that wore the Test lens in either the first or second period of the study.'}, {'id': 'OG001', 'title': 'Control (EMO-118)', 'description': 'Subjects that wore the Control lens in either the first or second period of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior mean difference of proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.000', 'ciLowerLimit': '-0.009', 'ciUpperLimit': '0.010', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0048', 'estimateComment': 'Interval presented is a 95% Credible interval', 'statisticalMethod': 'Bayesian hierarchical model', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'A 95% credible interval for the posterior mean difference between the Test and Control (Test - Control) was used to evaluate non-inferiority.', 'nonInferiorityComment': 'A non-inferiority margin of 10% was used. A 10% of difference in the rate of lens fit acceptance is considered clinically significant.'}], 'paramType': 'NUMBER', 'timeFrame': '10 minutes post lens insertion', 'description': 'Lens fit acceptance was assessed post lens fitting for each subject eye using a biomicroscope. Acceptable fit was a binary response where Y=1 if lens fit was deemed acceptable by the investigator and Y=0 otherwise. An unacceptable fit was observed if any of the following criteria were met: 1.) limbal exposure at primary gaze or with extreme eye movement, 2.) edge lift, 3.) excessive movement in primary and up gaze or 4.) insufficient movement in the three conditions- primary gaze, up gaze and Josephson push up. Time Frame 10 minutes post lens insertion', 'unitOfMeasure': 'Percentage of acceptable lens fit', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All subjects that were fitted at least one study lens'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test (EMO-200) \\Control (EMO-118)', '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 (EMO-118) \\Test (EMO-200)', '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': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 60 subjects were enrolled in this study. Of those enrolled, 57 subjects were dispensed both study lenses and completed all study visits.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total', 'description': 'All subjects dispensed a study lens'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'spread': '1.32', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All subjects dispensed a study lens'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-06', 'size': 23101970, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-16T07:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'dispFirstSubmitDate': '2022-08-12', 'completionDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2021-06-15', 'resultsFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2021-06-28', 'dispFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-20', 'studyFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monocular Distance Visual Acuity (logMAR)', 'timeFrame': '10 minutes post lens insertion', 'description': 'Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by- letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.00 is equivalent to Snellen visual acuity of 20/20.'}], 'secondaryOutcomes': [{'measure': "Percentage of Subjects' Eyes With Acceptable Lens Fit", 'timeFrame': '10 minutes post lens insertion', 'description': 'Lens fit acceptance was assessed post lens fitting for each subject eye using a biomicroscope. Acceptable fit was a binary response where Y=1 if lens fit was deemed acceptable by the investigator and Y=0 otherwise. An unacceptable fit was observed if any of the following criteria were met: 1.) limbal exposure at primary gaze or with extreme eye movement, 2.) edge lift, 3.) excessive movement in primary and up gaze or 4.) insufficient movement in the three conditions- primary gaze, up gaze and Josephson push up. Time Frame 10 minutes post lens insertion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isUnapprovedDevice': True}, 'conditionsModule': {'conditions': ['Visual Acuity']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized, controlled, double-masked, 2x2 cross-over, non-dispensing study to compare visual acuity and lens fit performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Potential subjects must satisfy all of the following criteria to be enrolled in the study:\n\n 1. The subject's parents or legal guardians must read, understand, and sign the STATEMENT OF INFORMED CONSENT (Parental Permission Form and Authorization to Use and Disclose Medical Information). The subject must read (or be read to) and sign the CHILDREN'S ASSENT (Information and Assent Form) and receive a fully executed copy of the form.\n 2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.\n 3. Between 7 and 12 (inclusive) years of age at the time of screening.\n 4. Have normal eyes (i.e., no ocular medications or infections of any type).\n 5. Have non-vertex corrected subjective spherical distance refraction in the range of -0.75 D to -4.50 D (inclusive) in each eye.\n 6. Have refractive cylinder in the range of 0.00 D to -1.00 D (inclusive) in each eye with any degree of axis, by subjective sphero-cylindrical refraction.\n 7. Have sphero-cylindrical best-corrected visual acuity of 0.04 logMAR (20/20-2) or better in each eye, and the difference of sphero-cylindrical best-corrected visual acuity between the two eyes is less than 0.20 logMAR (2 lines).\n 8. Have \\< 1.50 D difference in subjective best-sphere refraction between the two eyes.\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. Have any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g., rheumatoid arthritis), any underlying medical condition that makes subjects at risk of severe COVID complications, or other diseases, by parent of legal guardian's self-report, which are known to interfere with contact lens wear and/or participation in the study.\n 3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear and/or participation in the study.\n 4. Any current use of ocular medication (occasional use of re-wetting drops is allowed).\n 5. Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).\n 6. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.\n 7. Current or recent (within 60 days from enrollment) wear of orthokeratology lenses.\n 8. Current or recent (within 30 days from enrollment) rigid lens wearers.\n 9. Immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).\n 10. Children who are wards of the State or any other agency, institution, or entity.\n 11. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, ocular hypertension, glaucoma, history of recurrent corneal erosions, aphakia, uveitis, severe keratoconjunctivitis sicca, keratoconus, keratoconus suspect, and pellucid marginal degeneration.\n 12. Grade 3 or greater palpebral conjunctival observations or any other Grade 2 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, conjunctival injection) on the ISO 11980 classification scale.\n 13. 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 or subjects' participation in the study.\n 14. Any central corneal scar.\n 15. Any corneal distortion resulting from ocular diseases or previous hard or rigid gas permeable contact lens wear.\n 16. Binocular vision abnormality, intermittent strabismus or strabismus.\n 17. Pupil diameter under bright illumination is less than 2 mm in either eye."}, 'identificationModule': {'nctId': 'NCT04954833', 'briefTitle': 'Evaluating Visual Acuity and Initial Fit Performance of Two Soft Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'officialTitle': 'Evaluating Visual Acuity and Initial Fit Performance of Two Soft Contact Lenses', 'orgStudyIdInfo': {'id': 'CR-6441'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TEST/CONTROL', 'description': 'Eligible subjects will randomly be assigned to one of two unique sequences of the two lens types, Test/Control.', 'interventionNames': ['Device: EMO-200', 'Device: EMO-118']}, {'type': 'EXPERIMENTAL', 'label': 'CONTROL/TEST', 'description': 'Eligible subjects will randomly be assigned to one of two unique sequences of the two lens types, Control/Test.', 'interventionNames': ['Device: EMO-200', 'Device: EMO-118']}], 'interventions': [{'name': 'EMO-200', 'type': 'DEVICE', 'description': 'TEST Lens', 'armGroupLabels': ['CONTROL/TEST', 'TEST/CONTROL']}, {'name': 'EMO-118', 'type': 'DEVICE', 'description': 'CONTROL Lens', 'armGroupLabels': ['CONTROL/TEST', 'TEST/CONTROL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'William J. Bogus, OD', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, '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'}}}}