Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-28 @ 6:45 PM
Study NCT ID:
NCT01309867
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2011-03-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Performance of Two Designs of Soft Toric 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': 'robert.steffen@bausch.com', 'phone': '585-338-6399', 'title': 'Study Director', 'organization': 'Bausch Health'}, 'certainAgreement': {'otherDetails': 'Contact sponsor directly for details.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'description': 'Adverse events were not coded. Therefore, source vocabulary is not applicable. There were 302 eyes dispensed each lens group, assessed for adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Investigational Toric Lens', 'description': 'Bausch + Lomb investigational toric contact lenses\n\nInvestigational Toric Lens: Bausch \\& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.', 'otherNumAtRisk': 151, 'otherNumAffected': 0, 'seriousNumAtRisk': 151, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PureVision Toric Lens', 'description': 'Currently marketed Bausch + Lomb PureVision toric contact lenses\n\nPureVision Toric Lens: Currently marked Bausch \\& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.', 'otherNumAtRisk': 151, 'otherNumAffected': 0, 'seriousNumAtRisk': 151, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational Toric Lens', 'description': 'Bausch + Lomb investigational toric contact lenses\n\nInvestigational Toric Lens: Bausch \\& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.'}, {'id': 'OG001', 'title': 'PureVision Toric Lens', 'description': 'Currently marketed Bausch + Lomb PureVision toric contact lenses\n\nPureVision Toric Lens: Currently marked Bausch \\& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '489', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '2 weeks', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'There were 518 eyes in each group for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational Toric Lens', 'description': 'Bausch + Lomb investigational toric contact lenses\n\nInvestigational Toric Lens: Bausch \\& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.'}, {'id': 'OG001', 'title': 'PureVision Toric Lens', 'description': 'Currently marketed Bausch + Lomb PureVision toric contact lenses\n\nPureVision Toric Lens: Currently marked Bausch \\& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.025', 'spread': '0.106', 'groupId': 'OG000'}, {'value': '-0.021', 'spread': '0.106', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'There were 518 eyes in each group for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Symptoms and Complaints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '571', 'groupId': 'OG000'}, {'value': '571', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational Toric Lens', 'description': 'Bausch + Lomb investigational toric contact lenses\n\nInvestigational Toric Lens: Bausch \\& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.'}, {'id': 'OG001', 'title': 'PureVision Toric Lens', 'description': 'Currently marketed Bausch + Lomb PureVision toric contact lenses\n\nPureVision Toric Lens: Currently marked Bausch \\& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.'}], 'classes': [{'title': 'Burning/stinging upon insertion', 'categories': [{'measurements': [{'value': '85.4', 'spread': '28.1', 'groupId': 'OG000'}, {'value': '82.0', 'spread': '28.1', 'groupId': 'OG001'}]}]}, {'title': 'Comfort upon insertion', 'categories': [{'measurements': [{'value': '77.7', 'spread': '29.4', 'groupId': 'OG000'}, {'value': '74.3', 'spread': '29.4', 'groupId': 'OG001'}]}]}, {'title': 'Overall comfort', 'categories': [{'measurements': [{'value': '77.3', 'spread': '29.6', 'groupId': 'OG000'}, {'value': '67.9', 'spread': '29.6', 'groupId': 'OG001'}]}]}, {'title': 'Comfort at the end of the day', 'categories': [{'measurements': [{'value': '67.8', 'spread': '33.6', 'groupId': 'OG000'}, {'value': '57.6', 'spread': '33.6', 'groupId': 'OG001'}]}]}, {'title': 'Ease of handling/insertion', 'categories': [{'measurements': [{'value': '84.4', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '80.9', 'spread': '25.2', 'groupId': 'OG001'}]}]}, {'title': 'Ease of handling/removal', 'categories': [{'measurements': [{'value': '87.6', 'spread': '23.0', 'groupId': 'OG000'}, {'value': '83.7', 'spread': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'Dryness', 'categories': [{'measurements': [{'value': '73.6', 'spread': '32.1', 'groupId': 'OG000'}, {'value': '66.3', 'spread': '32.1', 'groupId': 'OG001'}]}]}, {'title': 'Itchiness', 'categories': [{'measurements': [{'value': '86.6', 'spread': '26.0', 'groupId': 'OG000'}, {'value': '82.0', 'spread': '26.0', 'groupId': 'OG001'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '88.0', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '83.5', 'spread': '23.9', 'groupId': 'OG001'}]}]}, {'title': 'Vision', 'categories': [{'measurements': [{'value': '82.0', 'spread': '28.3', 'groupId': 'OG000'}, {'value': '73.9', 'spread': '28.3', 'groupId': 'OG001'}]}]}, {'title': 'Lens Cleanliness', 'categories': [{'measurements': [{'value': '86.1', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '83.5', 'spread': '22.1', 'groupId': 'OG001'}]}]}, {'title': 'Overall impression', 'categories': [{'measurements': [{'value': '74.4', 'spread': '30.3', 'groupId': 'OG000'}, {'value': '64.2', 'spread': '30.3', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': "Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded at each post-dispensing visit based on the subject's experience with the study lens worn prior to the visit. The symptoms/complaints parameters were: Burning/stinging upon insertion; Comfort upon insertion, Overall comfort, and Comfort at the end of the day; Ease of handling/insertion, and Ease of handling/removal; Dryness; Itchiness; Redness; Vision; Lens cleanliness; and Overall impression.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'There were 571 eyes in each group assess for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Eyes With > Grade 2 Slit Lamp Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '600', 'groupId': 'OG000'}, {'value': '600', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational Toric Lens', 'description': 'Bausch + Lomb investigational toric contact lenses\n\nInvestigational Toric Lens: Bausch \\& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.'}, {'id': 'OG001', 'title': 'PureVision Toric Lens', 'description': 'Currently marketed Bausch + Lomb PureVision toric contact lenses\n\nPureVision Toric Lens: Currently marked Bausch \\& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '2 weeks', 'description': 'Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding \\> grade 2, across abnormalities.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'There were 600 eyes with non-missing scores in both groups for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Investigational Toric Lens Then PureVision Toric Lens', 'description': 'Bausch + Lomb investigational toric contact lenses\n\nInvestigational Toric Lens: Bausch \\& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.\n\nCurrently marketed Bausch + Lomb PureVision toric contact lenses PureVision Toric Lens: Currently marked Bausch \\& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.'}, {'id': 'FG001', 'title': 'PureVision Toric Lens Then Investigational Toric Lens', 'description': 'Currently marketed Bausch + Lomb PureVision toric contact lenses\n\nPureVision Toric Lens: Currently marked Bausch \\& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.\n\nBausch + Lomb investigational toric contact lenses Investigational Toric Lens: Bausch \\& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'A total of 151 participants (302 eyes) were randomized to receive test contact lenses and 151 participants (302 eyes) were randomized to receive control contact lenses. After two weeks of wearing the first lens type, the participants crossed over to the second lens type for two weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Participants were randomized 1:1 to receive test contact lenses or control contact lenses. After two weeks of wearing the first lens type, the participants crossed over to the second lens type for two weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'spread': '11.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '208', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '94', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A total of 151 participants were randomized to receive test contact lenses and 151 participants were randomized to receive control contact lenses. After two weeks of wearing the first lens type, the participants crossed over to the second lens type for two weeks.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 302}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2011-03-04', 'resultsFirstSubmitDate': '2020-08-21', 'studyFirstSubmitQcDate': '2011-03-04', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-05', 'studyFirstPostDateStruct': {'date': '2011-03-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees.', 'timeFrame': '2 weeks'}, {'measure': 'Visual Acuity', 'timeFrame': '2 weeks', 'description': 'Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).'}], 'secondaryOutcomes': [{'measure': 'Symptoms and Complaints', 'timeFrame': '2 weeks', 'description': "Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded at each post-dispensing visit based on the subject's experience with the study lens worn prior to the visit. The symptoms/complaints parameters were: Burning/stinging upon insertion; Comfort upon insertion, Overall comfort, and Comfort at the end of the day; Ease of handling/insertion, and Ease of handling/removal; Dryness; Itchiness; Redness; Vision; Lens cleanliness; and Overall impression."}, {'measure': 'Percentage of Eyes With > Grade 2 Slit Lamp Findings', 'timeFrame': '2 weeks', 'description': 'Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding \\> grade 2, across abnormalities.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have clear central corneas and be free of any anterior segment disorders.\n* Subjects must be adapted lens wearers, wear a lens in each eye and each lens must be of the same manufacture and brand.\n* Subjects must be myopic and require lens correction\n* Subjects must be habitual wearers of toric soft contact lenses.\n\nExclusion Criteria:\n\n* Subjects with any systemic disease currently affecting ocular health or which in the Investigator\'s opinion may have an effect on ocular health during the course of the study.\n* Subjects using any systemic or topical medications that will, in the Investigator\'s opinion, affect ocular physiology or lens performance.\n* Subjects with an active ocular disease or who are using any ocular medication.\n* Subjects with any grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates, of ANY GRADE, are not eligible.\n* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator\'s judgment, interferes with contact lens wear.\n* Subjects who are allergic to any component in the study care products.'}, 'identificationModule': {'nctId': 'NCT01309867', 'briefTitle': 'A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses', 'orgStudyIdInfo': {'id': '680'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational Toric Lens', 'description': 'Bausch + Lomb investigational toric contact lenses', 'interventionNames': ['Device: Investigational Toric Lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PureVision Toric Lens', 'description': 'Currently marketed Bausch + Lomb PureVision toric contact lenses', 'interventionNames': ['Device: PureVision Toric Lens']}], 'interventions': [{'name': 'Investigational Toric Lens', 'type': 'DEVICE', 'description': 'Bausch \\& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.', 'armGroupLabels': ['Investigational Toric Lens']}, {'name': 'PureVision Toric Lens', 'type': 'DEVICE', 'description': 'Currently marked Bausch \\& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.', 'armGroupLabels': ['PureVision Toric 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': 'Beverly Barna', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}