Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT00636194
Status:
COMPLETED
Last Update Posted:
2011-12-13
First Post:
2008-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Performance of a Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robert.steffen@bausch.com', 'phone': '(585) 338-6399', 'title': 'Robert Steffen OD', 'organization': 'Bausch & Lomb'}, 'certainAgreement': {'otherDetails': 'The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.\n\nPrior to publication or presentation, a copy of the final text should be forwarded by the Investigator(s) to the Sponsor or its designee, for comment.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'B&L Multipurpose Solution', 'description': 'Bausch \\& Lomb Multipurpose Contact Lens Solution', 'otherNumAtRisk': 175, 'otherNumAffected': 0, 'seriousNumAtRisk': 175, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Alcon Multipurpose Solution', 'description': 'Alcon OptiFree Replenish Multipurpose Contact Lens Solution', 'otherNumAtRisk': 175, 'otherNumAffected': 0, 'seriousNumAtRisk': 175, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Assessment of Comfort and Cleanliness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B&L Multipurpose Solution', 'description': 'Bausch \\& Lomb Multipurpose Contact Lens Solution'}, {'id': 'OG001', 'title': 'Alcon Multipurpose Solution', 'description': 'Alcon OptiFree Replenish Multipurpose Contact Lens Solution'}], 'classes': [{'title': 'Cleanliness upon insertion', 'categories': [{'measurements': [{'value': '89.71', 'spread': '14.52', 'groupId': 'OG000'}, {'value': '89.26', 'spread': '14.52', 'groupId': 'OG001'}]}]}, {'title': 'Comfort upon insertion', 'categories': [{'measurements': [{'value': '87.45', 'spread': '15.56', 'groupId': 'OG000'}, {'value': '86.63', 'spread': '15.56', 'groupId': 'OG001'}]}]}, {'title': 'Cleanliness at end of day', 'categories': [{'measurements': [{'value': '82.98', 'spread': '18.54', 'groupId': 'OG000'}, {'value': '82.34', 'spread': '18.54', 'groupId': 'OG001'}]}]}, {'title': 'Comfort at end of day', 'categories': [{'measurements': [{'value': '80.14', 'spread': '19.41', 'groupId': 'OG000'}, {'value': '79.60', 'spread': '19.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days', 'description': 'Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All eyes'}, {'type': 'SECONDARY', 'title': 'Symptoms and Complaints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B&L Multipurpose Solution', 'description': 'Bausch \\& Lomb Multipurpose Contact Lens Solution'}, {'id': 'OG001', 'title': 'Alcon Multipurpose Solution', 'description': 'Alcon OptiFree Replenish Multipurpose Contact Lens Solution'}], 'classes': [{'title': 'Comfort', 'categories': [{'measurements': [{'value': '85.4', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '86.1', 'spread': '13.1', 'groupId': 'OG001'}]}]}, {'title': 'End of day comfort', 'categories': [{'measurements': [{'value': '79.2', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '79.3', 'spread': '15.1', 'groupId': 'OG001'}]}]}, {'title': 'Burning/stinging upon insertion', 'categories': [{'measurements': [{'value': '87.0', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '88.9', 'spread': '14.8', 'groupId': 'OG001'}]}]}, {'title': 'Irritation', 'categories': [{'measurements': [{'value': '86.4', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '88.2', 'spread': '14.6', 'groupId': 'OG001'}]}]}, {'title': 'Itching', 'categories': [{'measurements': [{'value': '89.2', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '90.3', 'spread': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'Dryness', 'categories': [{'measurements': [{'value': '80.6', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '81.9', 'spread': '15.7', 'groupId': 'OG001'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '89.2', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '90.0', 'spread': '12.7', 'groupId': 'OG001'}]}]}, {'title': 'Vision', 'categories': [{'measurements': [{'value': '89.8', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '89.4', 'spread': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'Lens cleanliness', 'categories': [{'measurements': [{'value': '86.6', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '86.9', 'spread': '13.1', 'groupId': 'OG001'}]}]}, {'title': 'Lens handling', 'categories': [{'measurements': [{'value': '90.8', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '90.4', 'spread': '11.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Scores on a scale from 0 to 100, with 100 being the most favorable. Eyes with multiple unscheduled visits in a visit category were counted once for their lowest score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All eligible, dispensed eyes'}, {'type': 'SECONDARY', 'title': 'Graded Slit Lamp Findings > Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B&L Multipurpose Solution', 'description': 'Bausch \\& Lomb Multipurpose Contact Lens Solution'}, {'id': 'OG001', 'title': 'Alcon Multipurpose Solution', 'description': 'Alcon OptiFree Replenish Multipurpose Contact Lens Solution'}], 'classes': [{'title': 'Epithelial edema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Epithelial microcysts', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Corneal staining', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Limbal injection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bulbar injection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Superior tarsal conjunctival abnormalities', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Corneal neovascularization', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Corneal infiltrates', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 week follow-up visit', 'description': 'Grade none (no findings) - grade 4 (severe findings). Eyes in the Test group were compared with eyes in the Control group. Slit lamp finding greater than Grade 2.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All dispensed, completed eyes'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'B&L Multipurpose Solution', 'description': 'Bausch \\& Lomb Multipurpose Contact Lens Solution'}, {'id': 'FG001', 'title': 'Alcon Multipurpose Solution', 'description': 'Alcon OptiFree Replenish Multipurpose Contact Lens Solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '175'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '175'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Study related symptoms and complaints', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '361 subjects (722 eyes) who are currently adapted silicone hydrogel contact lens wearers and are habitually using a lens care product for disinfecting lenses, were enrolled in this 2-Week study at approximately 14 investigative sites in Asia. Study start date was 2/16/2008 and last subject exited on 3/17/2008.', 'preAssignmentDetails': 'Fourteen Investigators enrolled 361 subjects in the study. Of these subjects, 347 successfully completed the study, 3 discontinued and 11 were ineligible at baseline, but were dispensed study materials'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '350', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'B&L Multipurpose Solution', 'description': 'Bausch \\& Lomb Multipurpose Contact Lens Solution'}, {'id': 'BG001', 'title': 'Alcon Multipurpose Solution', 'description': 'Alcon OptiFree Replenish Multipurpose Contact Lens Solution'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '350', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '350', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 361}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-07', 'studyFirstSubmitDate': '2008-03-07', 'resultsFirstSubmitDate': '2010-12-14', 'studyFirstSubmitQcDate': '2008-03-07', 'lastUpdatePostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-01-19', 'studyFirstPostDateStruct': {'date': '2008-03-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Assessment of Comfort and Cleanliness', 'timeFrame': '7 days', 'description': 'Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.'}], 'secondaryOutcomes': [{'measure': 'Symptoms and Complaints', 'timeFrame': '2 weeks', 'description': 'Scores on a scale from 0 to 100, with 100 being the most favorable. Eyes with multiple unscheduled visits in a visit category were counted once for their lowest score.'}, {'measure': 'Graded Slit Lamp Findings > Grade 2', 'timeFrame': '2 week follow-up visit', 'description': 'Grade none (no findings) - grade 4 (severe findings). Eyes in the Test group were compared with eyes in the Control group. Slit lamp finding greater than Grade 2.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adverse Effect of Contact Lens Solution']}, 'descriptionModule': {'briefSummary': 'To evaluate the product performance of a Bausch \\& Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects are adapted wearers of silicone hydrogel contact lenses\n* VA correctable to 0.3 LogMAR or better (driving vision)\n* Clear central cornea\n* Subject uses a lens care system on a regular basis\n\nExclusion Criteria:\n\n* Systemic disease affecting ocular health\n* Using systemic or topical medications\n* wear a monovision, multifocal or toric contact lenses\n* Any grade 2 or greater slit lamp findings'}, 'identificationModule': {'nctId': 'NCT00636194', 'briefTitle': 'Comparative Performance of a Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'Product Performance of Bausch & Lomb Multi-Purpose Solution Compared to Alcon Opti-Free Replenish Multi-Purpose Solution When Used With Silicone Hydrogel Contact Lenses Worn on a Daily Wear Basis', 'orgStudyIdInfo': {'id': '562'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B&L Multipurpose solution', 'description': 'Bausch \\& Lomb Multipurpose Contact Lens Solution', 'interventionNames': ['Device: Bausch & Lomb Multipurpose Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alcon Multipurpose Solution', 'description': 'Alcon OptiFree Replenish Multipurpose Contact Lens Solution', 'interventionNames': ['Device: Alcon OptiFree Replenish Multipurpose Solution']}], 'interventions': [{'name': 'Bausch & Lomb Multipurpose Solution', 'type': 'DEVICE', 'description': 'daily care of contact lenses', 'armGroupLabels': ['B&L Multipurpose solution']}, {'name': 'Alcon OptiFree Replenish Multipurpose Solution', 'type': 'DEVICE', 'description': 'daily care for contact lenses', 'armGroupLabels': ['Alcon Multipurpose Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80400', 'city': 'Jalan Kuning, Tamn Pelangi', 'state': 'Johor Bahru', 'country': 'Malaysia', 'facility': 'Laser Focus Sdn Bhd, Vision Correction Centre'}], 'overallOfficials': [{'name': 'Mohinder Merchea, OD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}