Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-31 @ 9:05 PM
Study NCT ID:
NCT01722604
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2012-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C111827', 'term': 'brinzolamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Daniel.Donatello@bausch.com', 'phone': '(585) 338-5306', 'title': 'Daniel Donatello', 'organization': 'Bausch & Lomb'}, 'certainAgreement': {'otherDetails': 'Please contact sponsor directly for details.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Brinzolamide 1% Ophthalmic Suspension', 'description': 'ophthalmic suspension\n\nbrinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension', 'otherNumAtRisk': 129, 'deathsNumAtRisk': 129, 'otherNumAffected': 9, 'seriousNumAtRisk': 129, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Azopt 1% Ophthalmic Suspension', 'description': 'Ophthalmic suspension\n\nAzopt 1%: Azopt 1%, RLD', 'otherNumAtRisk': 129, 'deathsNumAtRisk': 129, 'otherNumAffected': 5, 'seriousNumAtRisk': 129, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Instillation site complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraocular Pressure (IOP) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brinzolamide 1% Ophthalmic Suspension', 'description': 'ophthalmic suspension\n\nbrinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension'}, {'id': 'OG001', 'title': 'Azopt 1% Ophthalmic Suspension', 'description': 'Ophthalmic suspension\n\nAzopt 1%: Azopt 1%, RLD'}], 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'spread': '3.21', 'groupId': 'OG000'}, {'value': '20.8', 'spread': '3.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol (PP) Population was utilized for the primary outcome. All randomized participants who completed both the baseline visit (eligibility visit 2) and the week 12 visit and who had no major protocol violations, and who also completed week 4 and week 8 visits, were included in the PP population.'}, {'type': 'SECONDARY', 'title': 'Change in Intraocular Pressure (IOP) From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brinzolamide 1% Ophthalmic Suspension', 'description': 'ophthalmic suspension\n\nbrinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension'}, {'id': 'OG001', 'title': 'Azopt 1% Ophthalmic Suspension', 'description': 'Ophthalmic suspension\n\nAzopt 1%: Azopt 1%, RLD'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.3', 'spread': '2.79', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '3.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol (PP) Population was utilized for the secondary outcome. All randomized participants who completed both the baseline visit (eligibility visit 2) and the week 12 visit and who had no major protocol violations, and who also completed week 4 and week 8 visits, were included in the PP population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brinzolamide 1% Ophthalmic Suspension', 'description': 'ophthalmic suspension\n\nbrinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension'}, {'id': 'FG001', 'title': 'Azopt 1% Ophthalmic Suspension', 'description': 'Ophthalmic suspension\n\nAzopt 1%: Azopt 1%, RLD'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '129'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Brinzolamide 1% Ophthalmic Suspension', 'description': 'ophthalmic suspension\n\nbrinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension'}, {'id': 'BG001', 'title': 'Azopt 1% Ophthalmic Suspension', 'description': 'Ophthalmic suspension\n\nAzopt 1%: Azopt 1%, RLD'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.1', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '91'}, {'value': '65.3', 'groupId': 'BG001', 'lowerLimit': '39', 'upperLimit': '89'}, {'value': '64.6', 'groupId': 'BG002', 'lowerLimit': '39', 'upperLimit': '91'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', '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': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '194', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 258}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'dispFirstSubmitDate': '2019-03-29', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-07', 'studyFirstSubmitDate': '2012-11-05', 'dispFirstSubmitQcDate': '2019-03-29', 'resultsFirstSubmitDate': '2021-05-14', 'studyFirstSubmitQcDate': '2012-11-06', 'dispFirstPostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-08', 'studyFirstPostDateStruct': {'date': '2012-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure (IOP) at Week 12', 'timeFrame': 'Week 12'}], 'secondaryOutcomes': [{'measure': 'Change in Intraocular Pressure (IOP) From Baseline to Week 12', 'timeFrame': 'Baseline, Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma', 'Open Angle or Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and females 18 years of age or older,\n* diagnosed with primary open-angle glaucoma or ocular hypertension.\n\nExclusion Criteria:\n\n* Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle glaucoma,\n* ocular hypertension.'}, 'identificationModule': {'nctId': 'NCT01722604', 'briefTitle': 'Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'orgStudyIdInfo': {'id': 'CD-11-265'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Azopt 1% ophthalmic suspension', 'description': 'Ophthalmic suspension', 'interventionNames': ['Drug: Azopt 1%']}, {'type': 'EXPERIMENTAL', 'label': 'Brinzolamide 1% ophthalmic suspension', 'description': 'ophthalmic suspension', 'interventionNames': ['Drug: brinzolamide 1% ophthalmic suspension']}], 'interventions': [{'name': 'brinzolamide 1% ophthalmic suspension', 'type': 'DRUG', 'description': 'brinzolamide 1% ophthalmic suspension', 'armGroupLabels': ['Brinzolamide 1% ophthalmic suspension']}, {'name': 'Azopt 1%', 'type': 'DRUG', 'description': 'Azopt 1%, RLD', 'armGroupLabels': ['Azopt 1% ophthalmic suspension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'US01', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}