Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-02-25 @ 11:01 PM
Study NCT ID:
NCT02252133
Status:
COMPLETED
Last Update Posted:
2016-01-29
First Post:
2014-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
DAILIES TOTAL1® Lens Centration in a Japanese Population
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'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': 'Senior Manager, Clinical Development, Japan', 'organization': 'Alcon Research, 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 for the duration of a subject's participation in the study (up to 14 days). AEs were obtained through use of a subjective questionnaire.", 'description': 'An AE was 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.', 'eventGroups': [{'id': 'EG000', 'title': 'Dailies Total 1', 'description': 'All subjects who wore delefilcon A contact lenses', 'otherNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '1DAVTE', 'description': 'All subjects who wore narafilcon A contact lenses', 'otherNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Success Rate of Lens Centration After 7 ± 2 Days of Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dailies Total 1', 'description': 'Delefilcon A contact lenses during Period 1 or Period 2 for 7 days.'}, {'id': 'OG001', 'title': '1DAVTE', 'description': 'Narafilcon A contact lenses worn during Period 1 or Period 2 for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '86.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7, each product', 'description': 'Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as "optimal" or "slight decentration. One eye (study eye) was analyzed.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all subjects who used the study lenses and who met all inclusion criteria and did not meet any exclusion criteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DT1, Then 1DAVTE', 'description': 'Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.'}, {'id': 'FG001', 'title': '1DAVTE, Then DT1', 'description': 'Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 3 study centers located in Japan.', 'preAssignmentDetails': 'Of the 53 enrolled, 6 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (47).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'DAILIES TOTAL1® and 1-Day Acuvue® TruEye® contact lenses worn during Period 1 and Period 2 in a crossover assignment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.0', 'spread': '9.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis group includes all randomized subjects.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-24', 'studyFirstSubmitDate': '2014-09-26', 'resultsFirstSubmitDate': '2015-11-19', 'studyFirstSubmitQcDate': '2014-09-29', 'lastUpdatePostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-19', 'studyFirstPostDateStruct': {'date': '2014-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success Rate of Lens Centration After 7 ± 2 Days of Wear', 'timeFrame': 'Day 7, each product', 'description': 'Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as "optimal" or "slight decentration. One eye (study eye) was analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contact lenses', 'Myopia'], 'conditions': ['Myopia', 'Refractive Error']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sign Informed Consent document.\n* Habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis.\n* Symptoms of contact lens discomfort as defined by protocol.\n* Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D.\n* Cylinder, if present, less or equal to 0.75D in either eyes at Visit 1.\n* Vision correctable to 20/25 or 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.\n* Acceptable contact lens fit with both study contact lenses.\n* Willing to wear lenses every day for at least for a minimum of five days per week six hours per day, every day if possible and attend all study visits.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Currently wearing DT1 or 1DAVTE.\n* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.\n* Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator.\n* Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.\n* Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit.\n* History of herpetic keratitis, ocular surgery or irregular cornea.\n* Prior refractive surgery (e.g. LASIK, PRK, etc).\n* Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.\n* Judged ineligible as a patient in this clinical study by the investigator.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02252133', 'briefTitle': 'DAILIES TOTAL1® Lens Centration in a Japanese Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Pilot Evaluation of DAILIES TOTAL1® Lens Centration in a Japanese Population', 'orgStudyIdInfo': {'id': 'ALJ-V2014-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DT1, then 1DAVTE', 'description': 'Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.', 'interventionNames': ['Device: Delefilcon A contact lenses', 'Device: Narafilcon A contact lenses']}, {'type': 'OTHER', 'label': '1DAVTE, then DT1', 'description': 'Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.', 'interventionNames': ['Device: Delefilcon A contact lenses', 'Device: Narafilcon A contact lenses']}], 'interventions': [{'name': 'Delefilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['DAILIES TOTAL1®'], 'description': "Silicone hydrogel contact lenses (8.5 and 8.8 base curves) dispensed per manufacturer's guidelines for daily disposable wear", 'armGroupLabels': ['1DAVTE, then DT1', 'DT1, then 1DAVTE']}, {'name': 'Narafilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['1-DAY ACUVUE® TruEye®'], 'description': "Silicone hydrogel contact lenses (8.5 and 9.0 base curves) dispensed per manufacturer's guidelines for daily disposable wear", 'armGroupLabels': ['1DAVTE, then DT1', 'DT1, then 1DAVTE']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Contact Alcon Japan Ltd. for Trial Locations', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Senior Manager, Clinical Development', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Japan, Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}