Ignite Creation Date:
2025-12-25 @ 12:57 AM
Ignite Modification Date:
2025-12-27 @ 6:00 AM
Study NCT ID:
NCT01244893
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2010-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of ACUVUE® ADVANCE® PLUS Contact Lenses.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'BPALL@its.jnj.com', 'phone': '(904) 443-1290', 'title': 'Brian Pall, O.D., M.S., F.A.A.O. Senior Research Optometrist', 'organization': 'Johnson & Johnson Vision Care'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'AAP PreQ', 'description': 'Acuvue Advance Plus silicone hydrogel contact lenses will be used both pre- / post-qualification.', 'otherNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AAP PostQ', 'description': 'Acuvue Advance Plus silicone hydrogel contact lenses will be used both pre- / post-qualification.', 'otherNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Acuity (VA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acuvue Advance Plus preQ', 'description': 'Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days. Binocular measurements reported only.'}, {'id': 'OG001', 'title': 'Acuvue Advance Plus postQ', 'description': 'Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-8 days. Binocular measurements reported only.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.088', 'spread': '0.0328', 'groupId': 'OG000'}, {'value': '-0.083', 'spread': '0.0377', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.005', 'ciLowerLimit': '-0.00092', 'ciUpperLimit': '0.01045', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.003', 'estimateComment': 'The mean difference is calculated as the test lens - control lens.', 'groupDescription': 'Ho: after time period (6-8 days of lens wear), the test lens - control lens will be greater than or equal to the non-inferiority margin specified .\n\nHa: after time period, test-control will be less than the margin specified concluding that the test lens will be inferior to control lens in terms of LogMAR scale', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'This study uses -0.05 LogMAR as the non-inferiority margin.'}], 'paramType': 'MEAN', 'timeFrame': '6-8 days after lens wear', 'description': 'Snellen VA was measured to the nearest letter then converted to the logMAR scale for the analysis. Values \\< 0 imply a clinically positive result; while values \\> 0 infer a clinically negative result.', 'unitOfMeasure': 'logMAR scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population analyzed are those who were enrolled, randomized, and completed the study.'}, {'type': 'SECONDARY', 'title': 'Corneal Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acuvue Advance Plus preQ', 'description': 'Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days.'}, {'id': 'OG001', 'title': 'Acuvue Advance Plus postQ', 'description': 'Acuvue Advance Plus silicone hydrogel contact lens manufactured post to qualification were worn daily for 6-8 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.23', 'spread': '0.424', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.375', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-8 days after lens wear', 'description': 'Corneal staining type was assessed by Investigator using a slit lamp and graded on a 5-point scale; 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Population analyzed are those who were enrolled, randomized, and completed the study.'}, {'type': 'SECONDARY', 'title': 'Limbal Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acuvue Advance Plus preQ', 'description': 'Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days.'}, {'id': 'OG001', 'title': 'Acuvue Advance Plus postQ', 'description': 'Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-8 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'spread': '0.457', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.682', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-8 days after lens wear', 'description': 'Limbal redness was assessed by using a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population analyzed are those who were enrolled, randomized, and completed the study.'}, {'type': 'SECONDARY', 'title': 'Bulbar Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acuvue Advance Plus preQ', 'description': 'Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-9 days.'}, {'id': 'OG001', 'title': 'Acuvue Advance Plus postQ', 'description': 'Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-9 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'spread': '0.673', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.596', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-8 days after lens wear', 'description': 'Scale of 0 increasing to 4. 0=None, 4=Severe Redness', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population analyzed consisted of those who were enrolled, randomized, and completed the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acuvue Advance Plus preQ/Acuvue Advance Plus postQ', 'description': 'Arm 1:\n\nAcuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second.\n\nArm 2:\n\nAcuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn second.'}, {'id': 'FG001', 'title': 'Acuvue Advance Plus postQ/Acuvue Advance Plus preQ', 'description': 'Arm 1:\n\nAcuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn second.\n\nArm 2:\n\nAcuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn second.'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '1-Week Follow Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Final Visit', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '4 investigation sites were used within the U.S. for this study, with a study duration of Oct 23, 2010 to Nov 7, 2010.', 'preAssignmentDetails': '44 subjects enrolled; 42 completed as cohort, two subjects were discontinued.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects', 'description': 'Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'spread': '5.66', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '44 persons enrolled, 42 completed as cohort, 2 dropped due to: 1 non-trial related adverse event, and 1 protocol deviation'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2010-11-18', 'resultsFirstSubmitDate': '2013-08-29', 'studyFirstSubmitQcDate': '2010-11-18', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-12-16', 'studyFirstPostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity (VA)', 'timeFrame': '6-8 days after lens wear', 'description': 'Snellen VA was measured to the nearest letter then converted to the logMAR scale for the analysis. Values \\< 0 imply a clinically positive result; while values \\> 0 infer a clinically negative result.'}], 'secondaryOutcomes': [{'measure': 'Corneal Staining', 'timeFrame': '6-8 days after lens wear', 'description': 'Corneal staining type was assessed by Investigator using a slit lamp and graded on a 5-point scale; 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.'}, {'measure': 'Limbal Redness', 'timeFrame': '6-8 days after lens wear', 'description': 'Limbal redness was assessed by using a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.'}, {'measure': 'Bulbar Redness', 'timeFrame': '6-8 days after lens wear', 'description': 'Scale of 0 increasing to 4. 0=None, 4=Severe Redness'}]}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare ACUVUE® ADVANCE® Plus contact lenses made prior to process qualification (prePQ) against the ACUVUE® ADVANCE® Plus lenses made after the process qualification (postPQ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject must be at least 18 years of age and no more than 39 years of age.\n* The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study (minimum of 6 hours per day).\n* The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.\n* Any cylinder power must be ≤ -0.75D.\n* The subject must have visual acuity best correctable to 20/25+3 or better for each eye.\n* The subject must read and sign the Statement of Informed Consent.\n* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.\n\nExclusion Criteria:\n\n* Ocular or systemic allergies or disease which might interfere with contact lens wear.\n* Systemic disease or use of medication which might interfere with contact lens wear.\n* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.\n* Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.\n* Any ocular infection.\n* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.\n* Pregnancy or lactation.\n* Diabetes.\n* Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).\n* Habitual contact lens type is toric, multifocal, or is worn as extended wear."}, 'identificationModule': {'nctId': 'NCT01244893', 'briefTitle': 'Study of ACUVUE® ADVANCE® PLUS Contact Lenses.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'orgStudyIdInfo': {'id': 'CR-1636BI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Acuvue Advance Plus prePQ/Acuvue Advance Plus postPQ', 'description': 'Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to process qualification will be worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after process qualification will be worn second.', 'interventionNames': ['Device: Acuvue Advance Plus prePQ', 'Device: Acuvue Advance Plus postPQ']}, {'type': 'OTHER', 'label': 'Acuvue Advance Plus postPQ/Acuvue Advance Plus prePQ', 'description': 'Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to process qualification worn first and Acuvue Advance Plus silicone hydrogel contact lens manufactured after process qualification worn second.', 'interventionNames': ['Device: Acuvue Advance Plus prePQ', 'Device: Acuvue Advance Plus postPQ']}], 'interventions': [{'name': 'Acuvue Advance Plus prePQ', 'type': 'DEVICE', 'description': 'silicone hydrogel contact lens manufactured prior to equipment process qualification activities.', 'armGroupLabels': ['Acuvue Advance Plus postPQ/Acuvue Advance Plus prePQ', 'Acuvue Advance Plus prePQ/Acuvue Advance Plus postPQ']}, {'name': 'Acuvue Advance Plus postPQ', 'type': 'DEVICE', 'description': 'silicone hydrogel contact lens manufactured after equipment process qualification activities.', 'armGroupLabels': ['Acuvue Advance Plus postPQ/Acuvue Advance Plus prePQ', 'Acuvue Advance Plus prePQ/Acuvue Advance Plus postPQ']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Powell', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 40.15784, 'lon': -83.07519}}, {'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'city': 'Salem', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.29347, 'lon': -80.05476}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}