Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-28 @ 12:10 AM
Study NCT ID:
NCT01163760
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2008-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Two Daily Disposable Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '904-443-3088', 'title': 'Kurt Moody OD, FAAO', 'organization': 'Vistakon'}, 'certainAgreement': {'otherDetails': 'The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "The integrity of the subject reported data is suspect and not reflective of lens' performance due to a significant protocol deviation. Upon completion of the study it was found that subjects were unmasked and their data should be considered biased."}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Etafilcon A/ Ocufilcon D', 'description': 'etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ocufilcon D / Etafilcon A', 'description': 'ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second.', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Etafilcon A/ Etafilcon A', 'description': 'etafilcon A contact lenses worn first and second period.', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Oculfilcon D / Ocufilcon D', 'description': 'ocufilcon D contact lenses worn first and second period.', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lens Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etafilcon A', 'description': 'etafilcon A contact lenses worn in either the first or second period.'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'ocufilcon D contact lenses worn in either the first or second period.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.08', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '1.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-week follow-up', 'description': 'Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects analyzed were those who were enrolled, randomized, and completed the study.'}, {'type': 'SECONDARY', 'title': 'Comfort Throughout the Whole Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etafilcon A', 'description': 'etafilcon A contact lenses worn in either the first or second period.'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'ocufilcon D contact lenses worn in either the first or second period.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000'}, {'value': '36.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-week follow-up', 'description': 'Comfort throughout the day was evaluated via subjective question: "Comfort throughout the whole day" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects analyzed were those enrolled, randomized, and completed the study.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Comfort While Working on Computer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etafilcon A', 'description': 'etafilcon A contact lenses worn in either the first or second period.'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'ocufilcon D contact lenses worn in either the first or second period.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.0', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-week-follow-up', 'description': 'Comfort throughout the day was evaluated via subjective question: "Comfort while working on computer" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etafilcon A First, Then Ocufilcon D', 'description': 'etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second'}, {'id': 'FG001', 'title': 'Ocufilcon D First, Then Etafilcon A', 'description': 'ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second.'}, {'id': 'FG002', 'title': 'Etafilcon A First, Then Etafilcon A', 'description': 'etafilcon A contact lenses worn for both periods.'}, {'id': 'FG003', 'title': 'Ocufilcon D First, Then Ocufilcon D', 'description': 'Ocufilcon D contact lenses worn for both periods.'}], 'periods': [{'title': 'Period 1 (Fit)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 2 (Follow-up)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 3 (Fit)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 4 (Follow-up)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'There were 50 subjects enrolled in this single site study, located at Singapore University.', 'preAssignmentDetails': 'There were 50 patients enrolled and randomized, and 50 patients completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'Total number of completed participants are included in baseline measurements.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'spread': '4.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', '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': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2008-09-29', 'resultsFirstSubmitDate': '2008-10-01', 'studyFirstSubmitQcDate': '2010-06-18', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-06-18', 'studyFirstPostDateStruct': {'date': '2010-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comfort While Working on Computer', 'timeFrame': '1-week-follow-up', 'description': 'Comfort throughout the day was evaluated via subjective question: "Comfort while working on computer" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".'}], 'primaryOutcomes': [{'measure': 'Lens Comfort', 'timeFrame': '1-week follow-up', 'description': 'Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)'}], 'secondaryOutcomes': [{'measure': 'Comfort Throughout the Whole Day', 'timeFrame': '1-week follow-up', 'description': 'Comfort throughout the day was evaluated via subjective question: "Comfort throughout the whole day" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Refractive Error']}, 'descriptionModule': {'briefSummary': 'This study seeks to evaluate the clinical performance of two daily disposable contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be between 21 and 39 years of age.\n* Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.\n* Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).\n* Require a visual correction in both eyes (monovision allowed but no monofit).\n* Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes.\n* Astigmatism of 1.00D or less in both eyes.\n* Be able to wear the lens powers available for this study.\n* Be correctable to a visual acuity of 20/30 or better in each eye.\n* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:\n\n * No amblyopia.\n * No evidence of lid abnormality or infection.\n * No conjunctival abnormality or infection.\n * No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities).\n * No other active ocular disease.\n\nExclusion Criteria:\n\n* Requires concurrent ocular medication.\n* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.\n* Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.\n* Diabetic.\n* Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).\n* Extended lens wear in last 3 months.\n* PMMA or RGP lens wear in the previous 8 weeks.\n* Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.\n* Abnormal lacrimal secretions.\n* Pre-existing ocular irritation that would preclude contact lens fitting.\n* Keratoconus or other corneal irregularity.\n* Pregnancy, lactating or planning a pregnancy at the time of enrollment.\n* Participation in any concurrent clinical trial or in last 60 days."'}, 'identificationModule': {'nctId': 'NCT01163760', 'briefTitle': 'Clinical Evaluation of Two Daily Disposable Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'orgStudyIdInfo': {'id': 'CR-0706'}, 'secondaryIdInfos': [{'id': 'PRO-518'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'etafilcon A / ocufilcon D', 'description': 'etafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable', 'interventionNames': ['Device: etafilcon A', 'Device: ocufilcon D']}, {'type': 'OTHER', 'label': 'oculfilcon D / etafilcon A', 'description': 'ocufilcon D contact lens worn first, etafilcon A contact lens worn second', 'interventionNames': ['Device: etafilcon A', 'Device: ocufilcon D']}, {'type': 'OTHER', 'label': 'ocufilcon D / ocufilcon D', 'description': 'ocufilcon D contact lens worn first and second', 'interventionNames': ['Device: ocufilcon D']}, {'type': 'OTHER', 'label': 'etafilcon A / etafilcon A', 'description': 'etafilcon A contact lens worn first and second', 'interventionNames': ['Device: etafilcon A']}], 'interventions': [{'name': 'etafilcon A', 'type': 'DEVICE', 'description': 'daily disposable contact lens', 'armGroupLabels': ['etafilcon A / etafilcon A', 'etafilcon A / ocufilcon D', 'oculfilcon D / etafilcon A']}, {'name': 'ocufilcon D', 'type': 'DEVICE', 'description': 'daily disposable contact lens', 'armGroupLabels': ['etafilcon A / ocufilcon D', 'ocufilcon D / ocufilcon D', 'oculfilcon D / etafilcon A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Singapore Polytechnic University', 'class': 'UNKNOWN'}, {'name': 'Visioncare Research Ltd.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}