Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT01035905
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2009-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'priya.janakiraman@cibavision.com', 'phone': '1-800-241-7629', 'title': 'Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs', 'organization': 'CIBA VISION'}, 'certainAgreement': {'otherDetails': "For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '63 days, duration of the study', 'description': '4 weeks of exposure to product', 'eventGroups': [{'id': 'EG000', 'title': 'Nelfilcon A', 'description': 'Nelfilcon A contact lens', 'otherNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Narafilcon A', 'description': 'Narafilcon A contact lens', 'otherNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lens Awareness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nelfilcon A', 'description': 'Nelfilcon A contact lens'}, {'id': 'OG001', 'title': 'Narafilcon A', 'description': 'Narafilcon A contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks of wear', 'description': "Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nelfilcon A', 'description': 'Nelfilcon A contact lens'}, {'id': 'FG001', 'title': 'Narafilcon A', 'description': 'Narafilcon A contact lens'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nelfilcon A', 'description': 'Nelfilcon A contact lens'}, {'id': 'BG001', 'title': 'Narafilcon A', 'description': 'Narafilcon A contact lens'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '35.7', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '33.7', 'spread': '10.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-26', 'studyFirstSubmitDate': '2009-12-18', 'resultsFirstSubmitDate': '2010-09-27', 'studyFirstSubmitQcDate': '2009-12-18', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-09-27', 'studyFirstPostDateStruct': {'date': '2009-12-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lens Awareness', 'timeFrame': '4 weeks of wear', 'description': "Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of two different daily disposable contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months.\n* Habitually wear lenses for at least 8 hours per day and 4 days per week.\n* Report 2 or more qualifying symptoms with current contact lenses.\n* Able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense.\n* Other protocol-defined inclusion/exclusion criteria may apply.\n\nExclusion Criteria:\n\n* Eye injury or surgery within twelve weeks immediately prior to enrollment.\n* Currently enrolled in any clinical trial.\n* Any use of ocular medications, exclusive of contact lens rewetting drops.\n* History of corneal or refractive surgery.\n* Cylinder correction greater than 1.00 D\n* Current monovision contact lens wearers.\n* Other protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01035905', 'briefTitle': 'Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers', 'orgStudyIdInfo': {'id': 'P-337-C-030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nelfilcon A', 'description': 'Nelfilcon A contact lens', 'interventionNames': ['Device: Nelfilcon A contact lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Narafilcon A', 'description': 'Narafilcon A contact lens', 'interventionNames': ['Device: Narafilcon A contact lens']}], 'interventions': [{'name': 'Nelfilcon A contact lens', 'type': 'DEVICE', 'description': 'Daily disposable contact lens worn in a daily wear, daily disposable mode', 'armGroupLabels': ['Nelfilcon A']}, {'name': 'Narafilcon A contact lens', 'type': 'DEVICE', 'description': 'Daily disposable contact lens worn in a daily wear, daily disposable mode', 'armGroupLabels': ['Narafilcon A']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CIBA VISION', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}