Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-04-18 @ 9:05 AM
Study NCT ID:
NCT01561560
Status:
COMPLETED
Last Update Posted:
2014-01-07
First Post:
2012-03-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Jami Kern, PhD', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': 'Study data should not be disclosed to any third party for a period of three years after the termination of the study without prior written consent.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the duration of the study. The safety population includes all participants enrolled and exposed to Test Article.', 'description': 'An adverse event was defined as an event that caused, or had the potential to cause, unexpected or unwanted effects involving the safety of device users (including patients) or other persons.', 'eventGroups': [{'id': 'EG000', 'title': 'DAILIES TOTAL1', 'description': 'Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks', 'otherNumAtRisk': 119, 'otherNumAffected': 0, 'seriousNumAtRisk': 119, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TRUEYE', 'description': 'Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks', 'otherNumAtRisk': 121, 'otherNumAffected': 0, 'seriousNumAtRisk': 121, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'End-of-day Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DAILIES TOTAL1', 'description': 'Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks'}, {'id': 'OG001', 'title': 'TRUEYE', 'description': 'Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '2.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2', 'description': 'End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This reporting group includes all participants who finished the study, minus any major protocol deviations as determined by masked review.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DAILIES TOTAL1, Then TRUEYE', 'description': 'Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.'}, {'id': 'FG001', 'title': 'TRUEYE, Then DAILIES TOTAL1', 'description': 'Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.'}], 'periods': [{'title': 'First Two Weeks of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Time/job conflict', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Two Weeks of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from two study centers in Finland, three study centers in German, and three study centers in the UK.', 'preAssignmentDetails': 'Of the 123 participants enrolled, two were excluded prior to randomization. This reporting group includes all participants enrolled and exposed to Test Article (121).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'OVERALL', 'description': 'Delefilcon A contact lenses and narafilcon A contact lenses worn in randomized order. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.0', 'spread': '10.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants enrolled and exposed to Test Article'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-19', 'studyFirstSubmitDate': '2012-03-21', 'resultsFirstSubmitDate': '2013-11-19', 'studyFirstSubmitQcDate': '2012-03-21', 'lastUpdatePostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-19', 'studyFirstPostDateStruct': {'date': '2012-03-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'End-of-day Comfort', 'timeFrame': 'Week 2', 'description': 'End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DAILIES TOTAL1', 'contact lenses', 'myopia'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sign written Informed Consent Document.\n* Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses.\n* Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses.\n* Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.\n* Willing to wear study lenses for at least eight hours per day and at least five days per week.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Has not worn contact lenses before.\n* Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses.\n* Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.\n* Ocular surgery/trauma within the last six months.\n* Topical ocular or systemic use of antibiotics within seven days of enrollment.\n* Pregnant or nursing women.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01561560', 'briefTitle': 'Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses', 'orgStudyIdInfo': {'id': 'P-347-C-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DAILIES TOTAL1, then TRUEYE', 'description': 'Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.', 'interventionNames': ['Device: Delefilcon A contact lenses', 'Device: Narafilcon A contact lenses']}, {'type': 'OTHER', 'label': 'TRUEYE, then DAILIES TOTAL1', 'description': 'Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.', 'interventionNames': ['Device: Delefilcon A contact lenses', 'Device: Narafilcon A contact lenses']}], 'interventions': [{'name': 'Delefilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['DAILIES TOTAL1®'], 'description': 'CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two', 'armGroupLabels': ['DAILIES TOTAL1, then TRUEYE', 'TRUEYE, then DAILIES TOTAL1']}, {'name': 'Narafilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['1-DAY ACUVUE® TRUEYE™'], 'description': 'CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two', 'armGroupLabels': ['DAILIES TOTAL1, then TRUEYE', 'TRUEYE, then DAILIES TOTAL1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Alcon Call Center for Trial Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Camille Girault', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}