Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-11 @ 4:01 PM
Study NCT ID:
NCT03896633
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2019-03-28
Is 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': '5853385306', 'title': 'Daniel Donatello', 'organization': 'Bausch & Lomb'}, 'certainAgreement': {'otherDetails': 'Contact sponsor directly for details.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'description': 'One Brinzolamide participant did not receive treatment and is not included in the participant counts for safety. Two Brinzolamide participants received at least one dose of Azopt in error, and therefore the Azopt group has 2 additional participants for safety.', 'eventGroups': [{'id': 'EG000', 'title': 'Brinzolamide 1% Ophthalmic Suspension', 'description': 'ophthalmic suspension\n\nbrinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension', 'otherNumAtRisk': 320, 'deathsNumAtRisk': 320, 'otherNumAffected': 15, 'seriousNumAtRisk': 320, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Azopt 1% Ophthalmic Suspension', 'description': 'Ophthalmic suspension\n\nAzopt 1%: Azopt 1%, RLD', 'otherNumAtRisk': 318, 'deathsNumAtRisk': 318, 'otherNumAffected': 22, 'seriousNumAtRisk': 318, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraocular Pressure (IOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '296', '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': '20.07', 'spread': '3.269', 'groupId': 'OG000'}, {'value': '19.89', 'spread': '3.183', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol Population was utilized for the primary outcome, included all randomized participants who met all inclusion/exclusion criteria, instilled 75% to 125% of the planned doses for the entire duration of the study, as verified by diaries, and who did not miss the scheduled applications for more than 3 consecutive days, and completed evaluations at Day 14 and Day 42 within the designated visit window (± 4 days) with no protocol deviations that would affect the treatment evaluation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Intraocular Pressure (IOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '296', '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': '-4.85', 'spread': '2.792', 'groupId': 'OG000'}, {'value': '-4.70', 'spread': '2.861', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Change in intraocular pressure (IOP) from baseline (Eligibility Visit 2) and after treatment.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol Population was utilized for this outcome; included all randomized participants who met all inclusion/exclusion criteria, instilled 75% to 125% of the planned doses for the entire duration of the study, as verified by diaries, and who did not miss the scheduled applications for more than 3 consecutive days, and completed evaluations at Day 14 and Day 42 within the designated visit window (± 4 days) with no protocol deviations that would affect the treatment evaluation.'}]}, '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': '321'}, {'groupId': 'FG001', 'numSubjects': '316'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '312'}, {'groupId': 'FG001', 'numSubjects': '306'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'BG000'}, {'value': '316', 'groupId': 'BG001'}, {'value': '637', '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': '65.1', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '91'}, {'value': '63.8', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '90'}, {'value': '64.4', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '91'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '248', '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': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '443', '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-12', 'size': 906712, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-14T14:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 637}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'dispFirstSubmitDate': '2019-05-20', 'completionDateStruct': {'date': '2018-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-07', 'studyFirstSubmitDate': '2019-03-28', 'dispFirstSubmitQcDate': '2019-05-20', 'resultsFirstSubmitDate': '2021-05-14', 'studyFirstSubmitQcDate': '2019-03-29', 'dispFirstPostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-14', 'studyFirstPostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Intraocular Pressure (IOP)', 'timeFrame': '6 weeks', 'description': 'Change in intraocular pressure (IOP) from baseline (Eligibility Visit 2) and after treatment.'}], 'primaryOutcomes': [{'measure': 'Intraocular Pressure (IOP)', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': 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 compared with AzoptTM', 'detailedDescription': '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': 'NCT03896633', 'briefTitle': 'Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'A BIOEQUIVALENCE STUDY OF THE GENERIC BRINZOLAMIDE 1% OPHTHALMIC SUSPENSION COMPARED TO REFERENCE LISTED DRUG AZOPT® (BRINZOLAMIDE) OPHTHALMIC SUSPENSION 1% IN SUBJECTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION', 'orgStudyIdInfo': {'id': '883'}}, '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', 'otherNames': ['brinzolamide'], 'description': 'brinzolamide 1% ophthalmic suspension', 'armGroupLabels': ['Brinzolamide 1% ophthalmic suspension']}, {'name': 'Azopt 1%', 'type': 'DRUG', 'otherNames': ['brinzolamide'], 'description': 'Azopt 1%, RLD', 'armGroupLabels': ['Azopt 1% ophthalmic suspension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Various', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}], 'overallOfficials': [{'name': 'Lindsey Mathew', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch Health Americas, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}