Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-01-07 @ 9:21 PM
Study NCT ID:
NCT02710292
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2016-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population
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 Manager', 'organization': 'Alcon Japan Ltd.'}, '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': "Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 26 days). AEs are reported as pretreatment and treatment-emergent.", 'description': "AEs were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). AE's were obtained as volunteered and elicited comments from the subjects and as observations by the Investigator.", 'eventGroups': [{'id': 'EG000', 'title': 'Pretreatment', 'description': 'All subjects who consented to participate in the study prior to initiation of study treatment', 'otherNumAtRisk': 104, 'otherNumAffected': 0, 'seriousNumAtRisk': 104, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dailies Total1', 'description': 'All subjects exposed to delefilcon A contact lenses', 'otherNumAtRisk': 96, 'otherNumAffected': 7, 'seriousNumAtRisk': 96, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'TruEye', 'description': 'All subjects exposed to narafilcon A contact lenses', 'otherNumAtRisk': 98, 'otherNumAffected': 23, 'seriousNumAtRisk': 98, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 19}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dailies Total1', 'description': 'Delefilcon A contact lenses worn bilaterally during Period 1 or Period 2 for for at least 7 days in a daily disposable modality.'}, {'id': 'OG001', 'title': 'TruEye', 'description': 'Narafilcon A contact lenses worn bilaterally during Period 1 or Period 2 for at least 7 days in a daily disposable modality.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000'}, {'value': '47.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 10, each product', 'description': 'Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all subjects who used the study device and in whom data after the use of the study device were available (Full Analysis Set).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DT1, Then TE', 'description': 'Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.'}, {'id': 'FG001', 'title': 'TE, Then DT1', 'description': 'Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.'}], 'periods': [{'title': 'Period 1, First 10 Days of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Period 2, Second 10 Days of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 6 study sites located in Japan.', 'preAssignmentDetails': 'Of the 104 subjects, 5 were exited as screen failures prior to being enrolled. This reporting group includes all enrolled subjects (99).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'Delefilcon A and narafilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.9', 'spread': '9.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all subjects who used the study device (Safety Analysis Set).'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-31', 'studyFirstSubmitDate': '2016-03-11', 'resultsFirstSubmitDate': '2017-05-08', 'studyFirstSubmitQcDate': '2016-03-11', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-08', 'studyFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear', 'timeFrame': 'Day 10, each product', 'description': 'Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Refractive Error']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must sign an informed consent form;\n* Habitual current daily disposable soft contact lenses wearer;\n* Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;\n* Lenses within the power range specified in the protocol;\n* Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1;\n* Acceptable lens fit with both study contact lenses;\n* Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits;\n* Other protocol-specified inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Currently wearing DT1 or TE sphere lenses;\n* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;\n* Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator;\n* Eye injury or surgery within 12 weeks immediately prior to enrollment;\n* History of herpetic keratitis, ocular surgery or irregular cornea;\n* Prior refractive surgery;\n* Monocular (only 1 eye with functional vision) or fit with only 1 lens;\n* Participation in any clinical trial within 30 days of the enrollment visit;\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02710292', 'briefTitle': 'Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Evaluation of DAILIES TOTAL 1® in Japanese Population - Comparison of Lens Centration Between DAILIES TOTAL 1® and 1-DAY ACUVUE® TruEye®', 'orgStudyIdInfo': {'id': 'CLS104-P001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DT1, then TE', 'description': 'Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.', 'interventionNames': ['Device: Delefilcon A contact lenses', 'Device: Narafilcon A contact lenses']}, {'type': 'OTHER', 'label': 'TE, then DT1', 'description': 'Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.', 'interventionNames': ['Device: Delefilcon A contact lenses', 'Device: Narafilcon A contact lenses']}], 'interventions': [{'name': 'Delefilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['DAILIES TOTAL 1®', 'DT1'], 'armGroupLabels': ['DT1, then TE', 'TE, then DT1']}, {'name': 'Narafilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['1-DAY ACUVUE® TruEye®'], 'armGroupLabels': ['DT1, then TE', 'TE, then DT1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '107-0052', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Contact Alcon Japan, Ltd. for Trial Locations', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Clinical Manager, Clinical Development', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Japan, Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}