Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-03-02 @ 4:55 PM
Study NCT ID:
NCT02694835
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2016-02-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Initial Performance of a Modified Daily Disposable Contact Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Clinical Project Lead, Vision Care', 'organization': 'Alcon, A Novartis Division'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Duration of enrollment = 1 Day', 'description': 'AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects/eyes exposed to any investigational product evaluated in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'DT1 UV', 'description': 'Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dailies Total1 (DT1)', 'description': 'Delefilcon A contact lenses worn bilaterally for 9 hours', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DT1 UV', 'description': 'Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours'}, {'id': 'OG001', 'title': 'Dailies Total1 (DT1)', 'description': 'Delefilcon A contact lenses worn bilaterally for 9 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Day 1 at Hour 9 ± 3 hours', 'description': 'An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DT1 UV', 'description': 'Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours'}, {'id': 'FG001', 'title': 'Dailies Total1 (DT1)', 'description': 'Delefilcon A contact lenses worn bilaterally for 9 hours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized and Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 5 investigational sites located in the United States.', 'preAssignmentDetails': 'Of the 81 enrolled, 1 subject exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (80).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DT1 UV', 'description': 'Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours'}, {'id': 'BG001', 'title': 'Dailies Total1 (DT1)', 'description': 'Delefilcon A contact lenses worn bilaterally for 9 hours'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.2', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '35.3', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '35.8', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Island', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Multi-Racial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all randomized subjects who were exposed to the investigational product and satisfied specific evaluability criteria (Full Analysis Set).'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2016-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-19', 'studyFirstSubmitDate': '2016-02-12', 'resultsFirstSubmitDate': '2019-01-22', 'studyFirstSubmitQcDate': '2016-02-24', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-22', 'studyFirstPostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs)', 'timeFrame': 'Day 1 at Hour 9 ± 3 hours', 'description': 'An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Refractive Error']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® with UV Absorber (DT1 UV) contact lenses compared with current DAILIES TOTAL1® (DT1) contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must sign an Informed Consent document;\n* Current wearers of commercial DT1 lenses (for at least 3 months), with a minimum wearing time of 5 days per week and 8 hours per day;\n* Spherical contact lens correction within the range of -2.00 to -4.00 Diopter (D) in both eyes;\n* Manifest astigmatism less than or equal to 0.75 D (at screening);\n* Best-corrected visual acuity (BCVA) greater than or equal to 20/25 in each eye (as determined by manifest refraction at screening);\n* Other protocol-specified inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Eye injury in either eye within 12 weeks prior to study enrollment;\n* Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the Investigator;\n* Use of systemic or ocular medications for which contact lens wear could be contraindicated, including topical ocular medications and lubrication drops that would require instillation during contact lens wear;\n* History of herpetic keratitis;\n* History of refractive surgery or irregular cornea;\n* Pathologically dry eye that precludes contact lens wear;\n* Concurrent participation (or within the previous 30 days) in a contact lens or lens care product clinical trial;\n* Monocular (only 1 eye with functional vision);\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02694835', 'briefTitle': 'Initial Performance of a Modified Daily Disposable Contact Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Initial Performance of a Modified Daily Disposable Silicone Hydrogel Contact Lens', 'orgStudyIdInfo': {'id': 'CLP691-C001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DT1 UV', 'description': 'Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours', 'interventionNames': ['Device: Delefilcon A contact lenses with UV Absorber']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DT1', 'description': 'Delefilcon A contact lenses worn bilaterally for 9 hours', 'interventionNames': ['Device: Delefilcon A contact lenses']}], 'interventions': [{'name': 'Delefilcon A contact lenses with UV Absorber', 'type': 'DEVICE', 'otherNames': ['DAILIES TOTAL1® UV (DT1 UV)'], 'armGroupLabels': ['DT1 UV']}, {'name': 'Delefilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['DAILIES TOTAL1® (DT1)'], 'armGroupLabels': ['DT1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Manager, GCRA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}