Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT01362894
Status:
COMPLETED
Last Update Posted:
2012-08-09
First Post:
2011-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Comparison of Two Daily Disposable Toric Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-241-7629', 'title': 'Stacie Cummings, O.D.', 'organization': 'Alcon Research, Ltd.'}, '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 events were collected for the duration of the study: 20-May-2011 to 15-AUG-2011.', 'description': 'The safety population included all enrolled and dispensed participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Nelfilcon A', 'description': 'Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.', 'otherNumAtRisk': 234, 'otherNumAffected': 0, 'seriousNumAtRisk': 234, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Etafilcon A', 'description': 'Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.', 'otherNumAtRisk': 235, 'otherNumAffected': 0, 'seriousNumAtRisk': 235, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Appendicitis', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Foot injury requiring hospitalization', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nelfilcon A', 'description': 'Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week, replacing lenses daily', 'description': 'As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.'}, {'type': 'PRIMARY', 'title': 'Overall Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nelfilcon A', 'description': 'Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week, replacing lenses daily', 'description': 'As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.'}, {'type': 'PRIMARY', 'title': 'Overall Handling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nelfilcon A', 'description': 'Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week, replacing lenses daily', 'description': 'As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.'}, {'type': 'PRIMARY', 'title': 'Overall Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nelfilcon A', 'description': 'Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week, replacing lenses daily', 'description': 'As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Ease of Selecting Final Lens Power', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nelfilcon A', 'description': 'Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nelfilcon A / Etafilcon A', 'description': 'Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.'}, {'id': 'FG001', 'title': 'Etafilcon A / Nelfilcon A', 'description': 'Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.'}], 'periods': [{'title': 'Period One, 1 Week', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One participant was not dispensed lenses until Period 2.', 'groupId': 'FG000', 'numSubjects': '119'}, {'comment': 'One participant was not dispensed lenses until Period 2.', 'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period Two, 1 Week', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Two participants discontinued between Periods 1 and 2 due to discomfort (1) and poor fit (1).', 'groupId': 'FG000', 'numSubjects': '118'}, {'comment': 'Three participants discontinued between Periods 1 and 2 due to unacceptable vision.', 'groupId': 'FG001', 'numSubjects': '115'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '115'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited and enrolled from 19 German study sites.', 'preAssignmentDetails': 'Two participants were enrolled, but not dispensed, due to unacceptable objective vision (1) and biomicroscopy findings (1). Baseline characteristics are presented on all enrolled and dispensed participants: 238.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'All enrolled and dispensed participants.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'spread': '9.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '159', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '238', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-03', 'studyFirstSubmitDate': '2011-05-27', 'resultsFirstSubmitDate': '2012-07-03', 'studyFirstSubmitQcDate': '2011-05-27', 'lastUpdatePostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-03', 'studyFirstPostDateStruct': {'date': '2011-06-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Vision', 'timeFrame': '1 week, replacing lenses daily', 'description': 'As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.'}, {'measure': 'Overall Comfort', 'timeFrame': '1 week, replacing lenses daily', 'description': 'As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.'}, {'measure': 'Overall Handling', 'timeFrame': '1 week, replacing lenses daily', 'description': 'As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.'}, {'measure': 'Overall Satisfaction', 'timeFrame': '1 week, replacing lenses daily', 'description': 'As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.'}], 'secondaryOutcomes': [{'measure': 'Ease of Selecting Final Lens Power', 'timeFrame': 'Day 0', 'description': 'As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia', 'Astigmatism']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial was to compare the performance of two contact lenses commercially available for people with astigmatism.', 'detailedDescription': 'This trial compared the performance of two commercialized daily disposable contact lenses in Germany.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sign written informed consent.\n* Germany: Be of legal age.\n* Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Eye injury or surgery within twelve weeks.\n* Pre-existing ocular irritation that would preclude contact lens fitting.\n* Currently enrolled in an ophthalmic clinical trial.\n* Wears contact lenses overnight while sleeping.\n* Habitual daily disposable contact lens wearer.\n* Monovision correction during the study.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01362894', 'briefTitle': 'Clinical Comparison of Two Daily Disposable Toric Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Comparison of Two Daily Disposable Toric Lenses', 'orgStudyIdInfo': {'id': 'P-346-C-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'nelfilcon A / etafilcon A', 'description': 'Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.', 'interventionNames': ['Device: nelfilcon A contact lens', 'Device: etafilcon A contact lens']}, {'type': 'OTHER', 'label': 'etafilcon A / nelfilcon A', 'description': 'Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.', 'interventionNames': ['Device: nelfilcon A contact lens', 'Device: etafilcon A contact lens']}], 'interventions': [{'name': 'nelfilcon A contact lens', 'type': 'DEVICE', 'otherNames': ['Focus® DAILIES® Toric'], 'description': 'Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.', 'armGroupLabels': ['etafilcon A / nelfilcon A', 'nelfilcon A / etafilcon A']}, {'name': 'etafilcon A contact lens', 'type': 'DEVICE', 'otherNames': ['1-DAY ACUVUE® MOIST® FOR ASTIGMATISM'], 'description': 'Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.', 'armGroupLabels': ['etafilcon A / nelfilcon A', 'nelfilcon A / etafilcon A']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CIBA VISION', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}