Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 5:01 PM
Study NCT ID:
NCT03605303
Status:
TERMINATED
Last Update Posted:
2019-08-28
First Post:
2018-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'BPALL@its.jnj.com', 'phone': '9044431290', 'title': 'Brian Pall OD, MS, FAAO - Director of Clinical Sciences', 'organization': 'Johnson & Johnson Vision Care Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was terminated after additional lens metrology testing revealed that the lens thickness of the contact lenses were thinner than the lens design targets. This reduction in thickness may have altered the handling of the contact lenses.'}}, 'adverseEventsModule': {'timeFrame': 'Throughout the entire duration of the study. Approxmiately 3 days per subject.', 'eventGroups': [{'id': 'EG000', 'title': 'Test', 'description': 'Subjects that wore the Test lens during any time throughout the duration of the study.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Subjects that wore the Control lens during any time throughout the duration of the study.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Comfort Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'subjects that were randomized to receive the Test lens in either period of the study.'}, {'id': 'OG001', 'title': 'Control', 'description': 'All subject that were randomized to the Control lens during either period of the study.'}], 'timeFrame': '1-Week Follow-up', 'description': 'Subjective assessment of comfort will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated early. No data was analyzed.'}, {'type': 'PRIMARY', 'title': 'Overall Vision Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'subjects that were randomized to receive the Test lens in either period of the study.'}, {'id': 'OG001', 'title': 'Control', 'description': 'All subject that were randomized to the Control lens during either period of the study.'}], 'timeFrame': '1-Week Follow-up', 'description': 'Subjective assessment of vision will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated early. No data was analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test/Control', 'description': 'Subjects that were radnomized to wear the Test lens during the period and the Control lens during the second period. Both study lens was was to be worn bilaterally for a period of 1-week each.'}, {'id': 'FG001', 'title': 'Control/Test', 'description': 'Subjects that were radnomized to wear the Control lens during the period and the Test lens during the second period. Both study lens was was to be worn bilaterally for a period of 1-week each.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Study Terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'On July 06, 2018 Johnson \\& Johnson Vision terminated this study prematurely after lens testing revealed that the lens thickness in the mid-periphery of the lens were thinner than the lens design targets. As of this date only 3 subjects were enrolled at 1 site.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Enrolled Subjects', 'description': 'All subjects enrolled into th study'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Other Pacfic Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-30', 'size': 8839511, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-03T11:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'This study was terminated due to the released lenses not representing what will be made commercially available and thus the objectives could not be met', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2018-07-20', 'resultsFirstSubmitDate': '2019-07-03', 'studyFirstSubmitQcDate': '2018-07-20', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-03', 'studyFirstPostDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Comfort Scores', 'timeFrame': '1-Week Follow-up', 'description': 'Subjective assessment of comfort will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.'}, {'measure': 'Overall Vision Score', 'timeFrame': '1-Week Follow-up', 'description': 'Subjective assessment of vision will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Refractive Error Correction']}, 'descriptionModule': {'briefSummary': 'This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n-Potential subjects must satisfy all of the following criteria to be enrolled in the study:\n\n1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.\n2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.\n3. Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.\n4. The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lens in both eyes (at least 1 month of daily wear).\n5. The subject must have normal eyes (i.e., no ocular medications or infections of any type).\n6. The subject's required spherical contact lens prescription must be in the range of -1.00 to -4.50 D in each eye.\n7. The subject's refractive cylinder must be \\< 0.75 D in each eye.\n8. The subject must have best corrected visual acuity of 20/25 or better in each eye.\n\nExclusion Criteria:\n\n1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).\n2. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.\n3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).\n4. Any ocular infection.\n5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.\n6. Monovision or multi-focal contact lens correction.\n7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.\n8. History of binocular vision abnormality or strabismus.\n9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).\n10. Suspicion of or recent history of alcohol or substance abuse.\n11. History of serious mental illness.\n12. History of seizures.\n13. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)."}, 'identificationModule': {'nctId': 'NCT03605303', 'briefTitle': 'Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'officialTitle': 'Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process', 'orgStudyIdInfo': {'id': 'CR-6270'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CONTROL- etafilcon A current molding', 'description': '1-Day ACUVUE® MOIST', 'interventionNames': ['Device: Test/Control', 'Device: Control/Test']}, {'type': 'EXPERIMENTAL', 'label': 'TEST- etafilcon A novel molding', 'description': 'Investigational Contact Lens', 'interventionNames': ['Device: Test/Control', 'Device: Control/Test']}], 'interventions': [{'name': 'Test/Control', 'type': 'DEVICE', 'description': 'Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Test/Control sequence with a 7 to 9-day washout period in between treatments', 'armGroupLabels': ['CONTROL- etafilcon A current molding', 'TEST- etafilcon A novel molding']}, {'name': 'Control/Test', 'type': 'DEVICE', 'description': 'Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Control/Test sequence with a 7 to 9-day washout period in between treatments', 'armGroupLabels': ['CONTROL- etafilcon A current molding', 'TEST- etafilcon A novel molding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Total Eye Care, PA', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}