Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-30 @ 11:36 AM
Study NCT ID:
NCT01254760
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2010-12-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}, {'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-241-7629', 'title': 'Director of Alcon Clinical', '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 event data were collected for the duration of the trial: 53 days', 'description': 'This reporting group includes all enrolled and exposed participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Nelfilcon A Investigational', 'description': 'Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 5 days', 'otherNumAtRisk': 77, 'otherNumAffected': 0, 'seriousNumAtRisk': 77, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nelfilcon A Commercial', 'description': 'Nelfilcon A commercial contact lenses worn in both eyes on a daily wear, daily disposable basis for 5 days', 'otherNumAtRisk': 77, 'otherNumAffected': 0, 'seriousNumAtRisk': 77, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'End of Day Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nelfilcon A Investigational', 'description': 'Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days'}, {'id': 'OG001', 'title': 'Nelfilcon A Commercial', 'description': 'Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days of wear, lenses replaced daily', 'description': 'End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', '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.'}, {'type': 'PRIMARY', 'title': 'End of Day Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nelfilcon A Investigational', 'description': 'Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days'}, {'id': 'OG001', 'title': 'Nelfilcon A Commercial', 'description': 'Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days of wear, lenses replaced daily', 'description': 'End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', '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.'}, {'type': 'PRIMARY', 'title': 'Handling at Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nelfilcon A Investigational', 'description': 'Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days'}, {'id': 'OG001', 'title': 'Nelfilcon A Commercial', 'description': 'Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days of wear, lenses replaced daily', 'description': 'Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', '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.'}, {'type': 'PRIMARY', 'title': 'Overall Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nelfilcon A Investigational', 'description': 'Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days'}, {'id': 'OG001', 'title': 'Nelfilcon A Commercial', 'description': 'Nelfilcon A commercial contact lenses worn in bilaterally on a daily wear, daily disposable basis for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days of wear, lenses replaced daily', 'description': 'Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', '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.'}, {'type': 'SECONDARY', 'title': 'Overall Fit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nelfilcon A Investigational', 'description': 'Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days'}, {'id': 'OG001', 'title': 'Nelfilcon A Commercial', 'description': 'Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 5, lenses replaced daily', 'description': "Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight", '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': 'Investigational Multifocal / Commercial Multifocal', 'description': 'Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.'}, {'id': 'FG001', 'title': 'Commercial Multifocal / Investigational Multifocal', 'description': 'Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.'}], 'periods': [{'title': 'First Period, 5 Days of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Period, 5 Days of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 79 participants were recruited at 7 US sites from December 3, 2010, to January 20, 2011.', 'preAssignmentDetails': 'Seven participants were enrolled in the study but not dispensed due to failed inclusion/exclusion criteria (2); unsatisfactory vision (2); unacceptable comfort (1); and subject withdrawal (2). These participants are included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'This reporting group includes all enrolled and dispensed participants.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.1', 'spread': '5.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', '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': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-26', 'studyFirstSubmitDate': '2010-12-03', 'resultsFirstSubmitDate': '2012-01-17', 'studyFirstSubmitQcDate': '2010-12-03', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-17', 'studyFirstPostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'End of Day Comfort', 'timeFrame': '5 days of wear, lenses replaced daily', 'description': 'End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.'}, {'measure': 'End of Day Dryness', 'timeFrame': '5 days of wear, lenses replaced daily', 'description': 'End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.'}, {'measure': 'Handling at Removal', 'timeFrame': '5 days of wear, lenses replaced daily', 'description': 'Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.'}, {'measure': 'Overall Vision', 'timeFrame': '5 days of wear, lenses replaced daily', 'description': 'Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.'}], 'secondaryOutcomes': [{'measure': 'Overall Fit', 'timeFrame': 'Day 5, lenses replaced daily', 'description': "Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Presbyopia', 'Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to evaluate and compare the clinical performance of two multifocal contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '41 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 41 to 68 (inclusive).\n* Spectacle add between +0.75 and +2.75D (inclusive).\n* Habitual spectacle prescription ≤ 1.00DC (cyl).\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Eye injury or surgery within twelve weeks of enrollment.\n* Pre-existing ocular irritation that would preclude contact lens fitting.\n* Currently enrolled in a clinical trial.\n* Prior refractive surgery.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01254760', 'briefTitle': 'Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'P-416-C-001 Sub 04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Investigational multifocal / Commercial multifocal', 'description': 'Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.', 'interventionNames': ['Device: Nelfilcon A multifocal contact lens, investigational', 'Device: Nelfilcon A multifocal contact lens, commercial']}, {'type': 'OTHER', 'label': 'Commercial multifocal / Investigational multifocal', 'description': 'Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.', 'interventionNames': ['Device: Nelfilcon A multifocal contact lens, investigational', 'Device: Nelfilcon A multifocal contact lens, commercial']}], 'interventions': [{'name': 'Nelfilcon A multifocal contact lens, investigational', 'type': 'DEVICE', 'description': 'Investigational, soft, multifocal contact lens for daily wear, daily disposable use.', 'armGroupLabels': ['Commercial multifocal / Investigational multifocal', 'Investigational multifocal / Commercial multifocal']}, {'name': 'Nelfilcon A multifocal contact lens, commercial', 'type': 'DEVICE', 'otherNames': ['Focus® DAILIES® Progressive'], 'description': 'Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.', 'armGroupLabels': ['Commercial multifocal / Investigational multifocal', 'Investigational multifocal / Commercial multifocal']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CIBA VISION', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}