Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT01297920
Status:
COMPLETED
Last Update Posted:
2013-07-04
First Post:
2011-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C111827', 'term': 'brinzolamide'}, {'id': 'D000068438', 'term': 'Brimonidine Tartrate'}], 'ancestors': [{'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Matt Walker, PhD, Clinical Project Lead', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to study drug.', 'description': 'An adverse event was any untoward medical occurrence in a subject exposed to study drug. The AE did not necessarily have to have had a causal relationship with the study drug. Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Brinz/Brim', 'description': 'Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months', 'otherNumAtRisk': 221, 'otherNumAffected': 53, 'seriousNumAtRisk': 221, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Brinzolamide', 'description': 'Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months', 'otherNumAtRisk': 234, 'otherNumAffected': 35, 'seriousNumAtRisk': 234, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Brimonidine', 'description': 'Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months', 'otherNumAtRisk': 235, 'otherNumAffected': 27, 'seriousNumAtRisk': 235, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 15}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Eye allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Aortic aneurysm repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nephrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Prostatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intervertebral disc operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Otitis media chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brinz/Brim', 'description': 'Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months'}, {'id': 'OG001', 'title': 'Brinzolamide', 'description': 'Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months'}, {'id': 'OG002', 'title': 'Brimonidine', 'description': 'Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months'}], 'classes': [{'title': '8 AM (before study drug instillation)', 'categories': [{'measurements': [{'value': '21.1', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '22.0', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '23.2', 'spread': '0.30', 'groupId': 'OG002'}]}]}, {'title': '+ 2 hours relative to 8 AM dosing', 'categories': [{'measurements': [{'value': '18.0', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '20.8', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '19.9', 'spread': '0.30', 'groupId': 'OG002'}]}]}, {'title': '+ 7 hours relative to 8 AM dosing', 'categories': [{'measurements': [{'value': '19.5', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '20.7', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '21.5', 'spread': '0.30', 'groupId': 'OG002'}]}]}, {'title': '+ 9 hours relative to 8 AM dosing', 'categories': [{'measurements': [{'value': '17.2', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '20.4', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '18.9', 'spread': '0.30', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month 3', 'description': 'The study drug was instilled at 8 AM and 3 PM (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).', 'unitOfMeasure': 'millimeters mercury (mm HG)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT): All subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Observed case analysis of the ITT dataset, per randomized treatment assignment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brinz/Brim', 'description': 'Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months'}, {'id': 'FG001', 'title': 'Brinzolamide', 'description': 'Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months'}, {'id': 'FG002', 'title': 'Brimonidine', 'description': 'Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '221'}, {'groupId': 'FG001', 'numSubjects': '234'}, {'groupId': 'FG002', 'numSubjects': '235'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '207'}, {'groupId': 'FG002', 'numSubjects': '178'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '57'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '38'}]}, {'type': 'Patient Decision Unrelated to AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Inadequate Control of IOP', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Patient Did Not Meet Entrance Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited and enrolled from 64 investigational centers in the United States.', 'preAssignmentDetails': 'Of the 1062 enrolled, 372 subjects did not meet inclusion/exclusion criteria and were exited from the study as screen failures prior to randomization. This reporting group includes all randomized subjects (690), as treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}, {'value': '690', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Brinz/Brim', 'description': 'Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months'}, {'id': 'BG001', 'title': 'Brinzolamide', 'description': 'Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months'}, {'id': 'BG002', 'title': 'Brimonidine', 'description': 'Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 64 years', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '327', 'groupId': 'BG003'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '363', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '387', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '303', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}, {'value': '690', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'This reporting group includes all randomized subjects, as treated.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1062}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-17', 'studyFirstSubmitDate': '2011-02-15', 'resultsFirstSubmitDate': '2013-05-17', 'studyFirstSubmitQcDate': '2011-02-16', 'lastUpdatePostDateStruct': {'date': '2013-07-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-17', 'studyFirstPostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3', 'timeFrame': 'Month 3', 'description': 'The study drug was instilled at 8 AM and 3 PM (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Open-Angle Glaucoma', 'Ocular Hypertension', 'Brinzolamide', 'Brimonidine', 'Intraocular pressure'], 'conditions': ['Open-Angle Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the safety and efficacy of a new ophthalmic suspension (Brinz/Brim) in lowering intraocular pressure (IOP) relative to its individual active components in subjects with open-angle glaucoma and/or ocular hypertension.', 'detailedDescription': 'This study consisted of 7 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and the treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 3 study drug groups. The study was designed to evaluate the efficacy and safety of Brinzolamide/Brimonidine over a 3-month period, with an additional 3 months of study drug exposure intended to provide further safety data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sign Informed Consent document.\n* Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.\n* Other protocol-specified inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.\n* Any form of glaucoma other than open-angle glaucoma.\n* Severe central vision loss in either eye.\n* Chronic, recurrent, or severe inflammatory eye disease.\n* Ocular trauma within the preceding 6 months.\n* Ocular infection or ocular inflammation within the preceding 3 months.\n* Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.\n* Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.\n* Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.\n* Ocular surgery within the preceding 6 months.\n* Ocular laser surgery within the preceding 3 months.\n* Any abnormality preventing reliable applanation tonometry.\n* Any other conditions, including severe illness, which could make the subject, in the opinion of the Investigator, unsuitable for the study.\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01297920', 'briefTitle': 'Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'A Three-Month, Randomized, Double-Masked, Parallel-Group Study With a Planned Three-Month Safety Extension of the Efficacy and Safety of a Fixed Combination of Brinzolamide 1%/Brimonidine 0.2% Compared to Brinzolamide 1% and Brimonidine 0.2% All Dosed Three Times Daily in Patients With Open-Angle Glaucoma and/or Ocular Hypertension', 'orgStudyIdInfo': {'id': 'C-10-039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brinz/Brim', 'description': 'Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months', 'interventionNames': ['Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brinzolamide', 'description': 'Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months', 'interventionNames': ['Drug: Brinzolamide ophthalmic suspension, 1%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brimonidine', 'description': 'Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months', 'interventionNames': ['Drug: Brimonidine tartrate ophthalmic solution, 0.2%']}], 'interventions': [{'name': 'Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension', 'type': 'DRUG', 'armGroupLabels': ['Brinz/Brim']}, {'name': 'Brinzolamide ophthalmic suspension, 1%', 'type': 'DRUG', 'armGroupLabels': ['Brinzolamide']}, {'name': 'Brimonidine tartrate ophthalmic solution, 0.2%', 'type': 'DRUG', 'armGroupLabels': ['Brimonidine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'James Teague, BS, Sr. Clinical Manager', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}