Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-27 @ 10:02 AM
Study NCT ID:
NCT01207466
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2010-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}, {'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joseph.rappon@cibavision.com', 'phone': '1-678-415-3343', 'title': 'Joe Rappon, OD, MS, FAAO / Head, Clinical Trial Management', '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': 'Adverse event data were collected for the duration of the trial: 45 days.', 'description': 'This reporting group includes all enrolled and exposed participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Nelfilcon A Investigational', 'description': 'Investigational, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.', 'otherNumAtRisk': 95, 'otherNumAffected': 0, 'seriousNumAtRisk': 95, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nelfilcon A Commercial', 'description': 'Commercially marketed, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.', 'otherNumAtRisk': 93, 'otherNumAffected': 0, 'seriousNumAtRisk': 93, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quality of Vision (Crisp and Clear)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nelfilcon A Investigational', 'description': 'Investigational, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.'}, {'id': 'OG001', 'title': 'Nelfilcon A Commercial', 'description': 'Commercially marketed, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week of wear', 'description': "Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "Nelfilcon A Invest'l / nelfilconA Comm'l", 'description': 'Nelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.'}, {'id': 'FG001', 'title': "Nelfilcon A Comm'l / nelfilconA Invest'l", 'description': 'Nelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.'}], 'periods': [{'title': 'Period 1, One Week of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One participant discontinued between Period 1 and Period 2 due to inclusion/exclusion criteria.', 'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2, One Week of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This reporting group includes all enrolled and dispensed participants. One participant was enrolled but not dispensed due to unacceptable fit. This participant is included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'This reporting group includes all enrolled and dispensed subjects.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.8', 'spread': '12.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-27', 'studyFirstSubmitDate': '2010-09-21', 'resultsFirstSubmitDate': '2011-07-28', 'studyFirstSubmitQcDate': '2010-09-21', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-28', 'studyFirstPostDateStruct': {'date': '2010-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Vision (Crisp and Clear)', 'timeFrame': '1 week of wear', 'description': "Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Astigmatism', 'Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to compare the performance of two contact lenses for contact lens wearers with astigmatism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently wearing soft contact lenses with astigmatism correction\n* Other protocol inclusion criteria may apply\n\nExclusion Criteria:\n\n* Eye injury or surgery within twelve weeks prior to enrollment\n* Currently enrolled in an ophthalmic clinical trial\n* Strabismus\n* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator\n* Other protocol exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01207466', 'briefTitle': 'Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'P-415-C-001 sub 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': "Nelfilcon A invest'l / nelfilconA comm'l", 'description': 'Nelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.', 'interventionNames': ['Device: Nelfilcon A investigational contact lens', 'Device: Nelfilcon A commercial contact lens']}, {'type': 'OTHER', 'label': "Nelfilcon A comm'l / nelfilconA invest'l", 'description': 'Nelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.', 'interventionNames': ['Device: Nelfilcon A investigational contact lens', 'Device: Nelfilcon A commercial contact lens']}], 'interventions': [{'name': 'Nelfilcon A investigational contact lens', 'type': 'DEVICE', 'description': 'Investigational, soft contact lens for astigmatism worn on a daily disposable basis.', 'armGroupLabels': ["Nelfilcon A comm'l / nelfilconA invest'l", "Nelfilcon A invest'l / nelfilconA comm'l"]}, {'name': 'Nelfilcon A commercial contact lens', 'type': 'DEVICE', 'otherNames': ['Focus DAILIES Toric'], 'description': 'Commercially marketed, soft contact lens for astigmatism worn on a daily disposable basis.', 'armGroupLabels': ["Nelfilcon A comm'l / nelfilconA invest'l", "Nelfilcon A invest'l / nelfilconA comm'l"]}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CIBA VISION', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}