Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT01309893
Status:
COMPLETED
Last Update Posted:
2014-11-24
First Post:
2011-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate a New Silicone Hydrogel Contact Lens
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': 'robert.steffen@bausch.com', 'phone': '585 338-6399', 'title': 'Dr. Robert Steffen', 'organization': 'Bausch & Lomb'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 week', 'eventGroups': [{'id': 'EG000', 'title': 'Investigational Lens', 'description': 'Bausch \\& Lomb investigational silicone hydrogel contact lens\n\nInvestigational Lens: Lenses worn on a daily wear basis for one week', 'otherNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Air Optix Aqua Lens', 'description': 'Ciba Vision Air Optix Aqua contact lens\n\nAir Optix Aqua lens: Lenses worn on a daily wear basis for one week', 'otherNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Distance High Contrast logMAR Visual Acuity at 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational Lens', 'description': 'Bausch \\& Lomb investigational silicone hydrogel contact lens\n\nInvestigational Lens: Lenses worn on a daily wear basis for one week'}, {'id': 'OG001', 'title': 'Air Optix Aqua Lens', 'description': 'Ciba Vision Air Optix Aqua contact lens\n\nAir Optix Aqua lens: Lenses worn on a daily wear basis for one week'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.031', 'spread': '0.069', 'groupId': 'OG000'}, {'value': '-0.015', 'spread': '0.071', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline & 1 week', 'description': 'Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All eligible, dispensed eyes'}, {'type': 'SECONDARY', 'title': 'Slit Lamp Findings ≥ Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational Lens', 'description': 'Bausch \\& Lomb investigational silicone hydrogel contact lens\n\nInvestigational Lens: Lenses worn on a daily wear basis for one week'}, {'id': 'OG001', 'title': 'Air Optix Aqua Lens', 'description': 'Ciba Vision Air Optix Aqua contact lens\n\nAir Optix Aqua lens: Lenses worn on a daily wear basis for one week'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Slit lamp findings are measured on a scale of 0-4, where 0=none, and 4=severe. The slit lamp exam is a routine procedure done to evaluate eye health and determine eligibility for clinical trial. It provides view of the different parts of the eye. During the exam, a doctor can look at the front parts of the eye, including the cornea, the lens, the iris and other parts of the anterior segment of the eye. Fluorescein dye may be used during a slit lamp examination to make it easier to detect inflammation, infections, or injured area on the cornea.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All dispensed eyes'}, {'type': 'SECONDARY', 'title': 'Overall Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational Lens', 'description': 'Bausch \\& Lomb investigational silicone hydrogel contact lens\n\nInvestigational Lens: Lenses worn on a daily wear basis for one week'}, {'id': 'OG001', 'title': 'Air Optix Aqua Lens', 'description': 'Ciba Vision Air Optix Aqua contact lens\n\nAir Optix Aqua lens: Lenses worn on a daily wear basis for one week'}], 'classes': [{'categories': [{'measurements': [{'value': '57.3', 'spread': '27.8', 'groupId': 'OG000'}, {'value': '80.8', 'spread': '27.2', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 week', 'description': 'Comfort measured by participant on a scale of 0-100 with 100 being the most favorable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All eligible dispensed eyes'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Investigational Lens First, Then Air Optix Aqua Lens', 'description': 'Enrolled participants spent 1 week using Investigational Lens, and then crossed over to 1 week using Air Optix Aqua lens. The order of contact lens use was randomized and participant-masked.'}, {'id': 'FG001', 'title': 'Air Optix Aqua Lens First, Then Investigational Lens', 'description': 'Enrolled participants spent 1 week using Air Optix Aqua Lens, and then crossed over to 1 week using Investigational Lens. The order of contact lens use was randomized and participant-masked.'}], 'periods': [{'title': 'Week 1 - First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Week 2 - Crossover Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Missed crossover visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants recruited for this 2-week study conducted at three investigational sites in the USA. The first participant was enrolled on 12/17/2010; the last participant exited the study on 01/20/2011.', 'preAssignmentDetails': '66 participants enrolled; 64 participants completed. Half wore Investigational Lens for 1 week then crossed over to Air Optix Aqua lens for 1 week. The other half wore Air Optix Aqua Lens for 1 week then crossed over to Investigational Lens for 1 week. The order of lens use was randomized and participant-masked.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'All eligible enrolled participants'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.6', 'spread': '9.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All eligible enrolled participants'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-20', 'studyFirstSubmitDate': '2011-03-04', 'resultsFirstSubmitDate': '2014-11-04', 'studyFirstSubmitQcDate': '2011-03-04', 'lastUpdatePostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-20', 'studyFirstPostDateStruct': {'date': '2011-03-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance High Contrast logMAR Visual Acuity at 1 Week', 'timeFrame': 'Baseline & 1 week', 'description': 'Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week'}], 'secondaryOutcomes': [{'measure': 'Slit Lamp Findings ≥ Grade 2', 'timeFrame': '1 week', 'description': 'Slit lamp findings are measured on a scale of 0-4, where 0=none, and 4=severe. The slit lamp exam is a routine procedure done to evaluate eye health and determine eligibility for clinical trial. It provides view of the different parts of the eye. During the exam, a doctor can look at the front parts of the eye, including the cornea, the lens, the iris and other parts of the anterior segment of the eye. Fluorescein dye may be used during a slit lamp examination to make it easier to detect inflammation, infections, or injured area on the cornea.'}, {'measure': 'Overall Comfort', 'timeFrame': '1 week', 'description': 'Comfort measured by participant on a scale of 0-100 with 100 being the most favorable.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contact lens'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.\n* Be myopic and require lens correction from -0.50 D to -5.50 D in each eye.\n\nExclusion Criteria:\n\n* Any systemic disease affecting ocular health.\n* Using any systemic or topical medications that will affect ocular physiology or lens performance.\n* An active ocular disease, any corneal infiltrative response or are using any ocular medications.\n* Any "Present" finding during the slit lamp examination that, in the Investigator\'s judgment, interferes with contact lens wear.\n* Allergic to any component in the study care products.'}, 'identificationModule': {'nctId': 'NCT01309893', 'briefTitle': 'A Study to Evaluate a New Silicone Hydrogel Contact Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens', 'orgStudyIdInfo': {'id': '687E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational Lens', 'description': 'Bausch \\& Lomb investigational silicone hydrogel contact lens for 1 week; then issued Air Optix Aqua Lens for 1 week.', 'interventionNames': ['Device: Investigational Lens', 'Device: Air Optix Aqua lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Air Optix Aqua Lens', 'description': 'Ciba Vision Air Optix Aqua contact lens for 1 week; then issued Investigational Lens for 1 week.', 'interventionNames': ['Device: Investigational Lens', 'Device: Air Optix Aqua lens']}], 'interventions': [{'name': 'Investigational Lens', 'type': 'DEVICE', 'description': 'Lenses worn on a daily wear basis for one week', 'armGroupLabels': ['Air Optix Aqua Lens', 'Investigational Lens']}, {'name': 'Air Optix Aqua lens', 'type': 'DEVICE', 'description': 'Lenses worn on a daily wear basis for one week', 'armGroupLabels': ['Air Optix Aqua Lens', 'Investigational Lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Bausch & Lomb', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Robert Steffen, OD, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}