Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2026-01-01 @ 3:26 PM
Study NCT ID:
NCT01024751
Status:
COMPLETED
Last Update Posted:
2011-08-15
First Post:
2009-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'william.reindel@bausch.com', 'phone': '(585) 338-8129', 'title': 'William Reindel, OD, MS', 'organization': 'Bausch & Lomb Incorporated'}, 'certainAgreement': {'otherDetails': 'All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. 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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 month', 'description': 'Adverse events measured by eye', 'eventGroups': [{'id': 'EG000', 'title': 'Bausch & Lomb Multi-Purpose Solution', 'description': 'Multi-Purpose Solution to be used for disinfecting contact lenses.', 'otherNumAtRisk': 156, 'otherNumAffected': 0, 'seriousNumAtRisk': 156, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': "Ciba's Multi-Purpose Solution", 'description': 'Multi-Purpose Solution to be used for disinfecting contact lenses.', 'otherNumAtRisk': 156, 'otherNumAffected': 0, 'seriousNumAtRisk': 156, 'seriousNumAffected': 0}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comfort-related Symptoms/Complaints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bausch & Lomb Multi-Purpose Solution', 'description': 'Multi-Purpose Solution to be used for disinfecting contact lenses.'}, {'id': 'OG001', 'title': "Ciba's Multi-Purpose Solution", 'description': 'Multi-Purpose Solution to be used for disinfecting contact lenses.'}], 'classes': [{'title': 'Comfort', 'categories': [{'measurements': [{'value': '89.0', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '88.3', 'spread': '14.7', 'groupId': 'OG001'}]}]}, {'title': 'End of Day Comfort', 'categories': [{'measurements': [{'value': '81.7', 'spread': '20.7', 'groupId': 'OG000'}, {'value': '81.9', 'spread': '17.4', 'groupId': 'OG001'}]}]}, {'title': 'Burning/stinging upon insertion', 'categories': [{'measurements': [{'value': '91.4', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '93.1', 'spread': '14.0', 'groupId': 'OG001'}]}]}, {'title': 'Irritation', 'categories': [{'measurements': [{'value': '88.2', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '89.3', 'spread': '14.1', 'groupId': 'OG001'}]}]}, {'title': 'Itching', 'categories': [{'measurements': [{'value': '91.2', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '94.3', 'spread': '10.3', 'groupId': 'OG001'}]}]}, {'title': 'Dryness', 'categories': [{'measurements': [{'value': '84.9', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '85.4', 'spread': '15.8', 'groupId': 'OG001'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '90.7', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '92.8', 'spread': '13.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At dispensing visit and each follow-up visit at week 2 and week 4.', 'description': 'Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Summaries included all eligible, dispensed participants, with participants summarized under the study products received.'}, {'type': 'SECONDARY', 'title': 'Slit Lamp Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bausch & Lomb Multi-Purpose Solution', 'description': 'Multi-Purpose Solution to be used for disinfecting contact lenses.'}, {'id': 'OG001', 'title': "Ciba's Multi-Purpose Solution", 'description': 'Multi-Purpose Solution to be used for disinfecting contact lenses.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Over all visits for 1 month', 'description': 'Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Greater than grade 2 for all dispensed eyes with non-missing scores'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bausch & Lomb Multi-Purpose Solution', 'description': 'Multi-Purpose Solution to be used for disinfecting contact lenses.'}, {'id': 'FG001', 'title': "Ciba's Multi-Purpose Solution", 'description': 'Multi-Purpose Solution to be used for disinfecting contact lenses.'}], 'periods': [{'title': 'Enrolled Participants', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}, {'groupId': 'FG001', 'numSubjects': '156'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Ineligible at baseline', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}, {'title': 'Eligible Participants', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This one month study was conducted at 20 sites by 20 investigators in the United States. First participant was enrolled 11/30/2009 and last Participants visit was 1/22/2010.', 'preAssignmentDetails': '312 participants(624 eyes) started the study, 7 of which were ineligible at baseline, one was non-dispensed. 305(610 eyes) participants were eligible. 3 participants were discontinued during the study. 302 participants (604 eyes) completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bausch & Lomb Multi-Purpose Solution', 'description': 'Multi-Purpose Solution to be used for disinfecting contact lenses.'}, {'id': 'BG001', 'title': "Ciba's Multi-Purpose Solution", 'description': 'Multi-Purpose Solution to be used for disinfecting contact lenses.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Between 18 and 70 years', 'categories': [{'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-11', 'studyFirstSubmitDate': '2009-11-30', 'resultsFirstSubmitDate': '2011-06-16', 'studyFirstSubmitQcDate': '2009-12-01', 'lastUpdatePostDateStruct': {'date': '2011-08-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-15', 'studyFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort-related Symptoms/Complaints', 'timeFrame': 'At dispensing visit and each follow-up visit at week 2 and week 4.', 'description': 'Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.'}], 'secondaryOutcomes': [{'measure': 'Slit Lamp Findings', 'timeFrame': 'Over all visits for 1 month', 'description': 'Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ocular Discomfort']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the clinical performance of Bausch \\& Lomb investigational Multi-Purpose Solution compared to Ciba Vision Multi-Purpose Solution when used by wearers of silicone hydrogel or Group IV contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.\n* Participants must habitually use a lens care product for lens cleaning, disinfecting, and storage.\n* Participants must wear a lens in each eye and each lens must be of the same manufacture and brand.\n* Participants must agree to wear study lenses on a daily wear basis.\n* Participants must be able and willing to comply with all treatment and follow-up/study procedures.\n\nExclusion Criteria:\n\n* Participants participating in any drug or device clinical investigation within 2 weeks prior to entry into this study and/or during the period of study participation.\n* Participants with any systemic disease affecting ocular health.\n* Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.\n* Participants who have had any corneal surgery (eg, refractive surgery).\n* Participants who are allergic to any component in the study care products."}, 'identificationModule': {'nctId': 'NCT01024751', 'briefTitle': 'A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution', 'orgStudyIdInfo': {'id': '636'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bausch & Lomb Multi-Purpose Solution', 'description': 'Multi-Purpose Solution to be used for disinfecting contact lenses.', 'interventionNames': ['Device: Bausch & Lomb Multi-Purpose Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': "Ciba's Multi-Purpose Solution", 'description': 'Multi-Purpose Solution to be used for disinfecting contact lenses.', 'interventionNames': ["Device: Ciba's Multi-Purpose Solution"]}], 'interventions': [{'name': 'Bausch & Lomb Multi-Purpose Solution', 'type': 'DEVICE', 'description': 'Lens care product for disinfecting lenses on a daily basis.', 'armGroupLabels': ['Bausch & Lomb Multi-Purpose Solution']}, {'name': "Ciba's Multi-Purpose Solution", 'type': 'DEVICE', 'description': 'Lens care product for disinfecting lenses on a daily basis.', 'armGroupLabels': ["Ciba's Multi-Purpose Solution"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Bausch & Lomb', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mohinder Merchea, OD, PhD, MBA', 'oldOrganization': 'Bausch & Lomb Incorporated'}}}}