Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-30 @ 4:36 PM
Study NCT ID:
NCT01937312
Status:
COMPLETED
Last Update Posted:
2015-07-28
First Post:
2013-09-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C111827', 'term': 'brinzolamide'}, {'id': 'D000068438', 'term': 'Brimonidine Tartrate'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D000069557', 'term': 'Travoprost'}, {'id': 'D000069580', 'term': 'Bimatoprost'}, {'id': 'D000077338', 'term': 'Latanoprost'}], 'ancestors': [{'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D003008', 'term': 'Cloprostenol'}, {'id': 'D011461', 'term': 'Prostaglandins F, Synthetic'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Global Brand Leader, Medical Affairs, Glaucoma', '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 (AEs) were collected for the duration of the study, Oct 2013-May 2014. Adverse events are reported as pre-treatment and treatment-emergent. The treatment-emergent analysis set included all subjects exposed to investigational product.', 'description': 'An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. All AEs were obtained as solicited and spontaneous comments from the subjects, and as observations by the Investigator, as outlined in the study protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-Treatment', 'description': 'Prostaglandin analogue, 1 drop in each eye at bedtime for a 4-week run-in period', 'otherNumAtRisk': 282, 'otherNumAffected': 2, 'seriousNumAtRisk': 282, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SIMBRINZA', 'description': '1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks', 'otherNumAtRisk': 93, 'otherNumAffected': 16, 'seriousNumAtRisk': 93, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Vehicle', 'description': '1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks', 'otherNumAtRisk': 95, 'otherNumAffected': 8, 'seriousNumAtRisk': 95, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Eye Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'seriousEvents': [{'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Metastatic malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Diurnal Intraocular Pressure (IOP) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SIMBRINZA', 'description': '1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks'}, {'id': 'OG001', 'title': 'Vehicle', 'description': '1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '17.01', 'spread': '2.897', 'groupId': 'OG000'}, {'value': '20.37', 'spread': '3.914', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6', 'description': 'Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.'}, {'type': 'SECONDARY', 'title': 'Mean Diurnal IOP Change From Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SIMBRINZA', 'description': '1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks'}, {'id': 'OG001', 'title': 'Vehicle', 'description': '1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.69', 'spread': '2.571', 'groupId': 'OG000'}, {'value': '-1.99', 'spread': '2.865', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.'}, {'type': 'SECONDARY', 'title': 'Mean Diurnal IOP Percentage Change From Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SIMBRINZA', 'description': '1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks'}, {'id': 'OG001', 'title': 'Vehicle', 'description': '1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.88', 'spread': '10.818', 'groupId': 'OG000'}, {'value': '-8.50', 'spread': '12.396', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.'}, {'type': 'SECONDARY', 'title': 'Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SIMBRINZA', 'description': '1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks'}, {'id': 'OG001', 'title': 'Vehicle', 'description': '1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks'}], 'classes': [{'title': '8 AM', 'categories': [{'measurements': [{'value': '19.4', 'spread': '3.53', 'groupId': 'OG000'}, {'value': '21.4', 'spread': '4.33', 'groupId': 'OG001'}]}]}, {'title': '10 AM', 'categories': [{'measurements': [{'value': '15.8', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '20.2', 'spread': '4.17', 'groupId': 'OG001'}]}]}, {'title': '3 PM', 'categories': [{'measurements': [{'value': '17.2', 'spread': '3.15', 'groupId': 'OG000'}, {'value': '19.9', 'spread': '4.28', 'groupId': 'OG001'}]}]}, {'title': '5 PM', 'categories': [{'measurements': [{'value': '15.6', 'spread': '3.14', 'groupId': 'OG000'}, {'value': '19.9', 'spread': '4.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6', 'description': 'IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SIMBRINZA', 'description': '1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks'}, {'id': 'FG001', 'title': 'Vehicle', 'description': '1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal of subject prior to treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited and enrolled from 30 investigative sites located in the US.', 'preAssignmentDetails': 'Of the 282 enrolled, 93 participants were exited from the study as screen failures prior to randomization. This reporting group includes all randomized participants (189). Note: One subject randomized to SIMBRINZA® Suspension was not exposed to investigational product.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SIMBRINZA', 'description': '1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks'}, {'id': 'BG001', 'title': 'Vehicle', 'description': '1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.5', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '64.7', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '65.1', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mean Diurnal Intraocular Pressure (IOP) at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '22.68', 'spread': '2.123', 'groupId': 'BG000'}, {'value': '22.39', 'spread': '2.774', 'groupId': 'BG001'}, {'value': '22.53', 'spread': '2.478', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Diurnal IOP at Baseline was defined as the average of the four Baseline IOP measurements at timepoints 8 AM, 10 AM, 3 PM, and 5 PM. For each timepoint, the baseline IOP was defined as the average of the timepoint-matched IOP measurements at the Eligibility 1 and Eligibility 2 Visits.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 282}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-06', 'studyFirstSubmitDate': '2013-09-04', 'resultsFirstSubmitDate': '2015-05-22', 'studyFirstSubmitQcDate': '2013-09-06', 'lastUpdatePostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-22', 'studyFirstPostDateStruct': {'date': '2013-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Diurnal Intraocular Pressure (IOP) at Week 6', 'timeFrame': 'Week 6', 'description': 'Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).'}], 'secondaryOutcomes': [{'measure': 'Mean Diurnal IOP Change From Baseline to Week 6', 'timeFrame': 'Baseline, Week 6', 'description': 'Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.'}, {'measure': 'Mean Diurnal IOP Percentage Change From Baseline to Week 6', 'timeFrame': 'Baseline, Week 6', 'description': 'Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.'}, {'measure': 'Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)', 'timeFrame': 'Week 6', 'description': 'IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye was chosen as the study eye and only data for the study eye were used for the 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': ['glaucoma', 'prostaglandin analogue', 'brinzolamide', 'brimonidine'], 'conditions': ['Ocular Hypertension', 'Open Angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.', 'detailedDescription': 'This study was divided into 2 sequential phases. The Screening/Eligibility Phase included one Screening Visit and two Eligibility Visits, during which subjects washed out of all other intraocular pressure (IOP)-lowering medications and dosed with TRAVATAN Z®, XALATAN®, or LUMIGAN®, 1 drop instilled in each eye once daily for 28 days. Subjects who met all inclusion/exclusion criteria were randomized at the second Eligibility Visit. The Treatment Phase consisted of two on-therapy visits (Week 2 and Week 6).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;\n* Mean intraocular pressure (IOP) measurements in at least 1 eye (study eye) of ≥ 21 mmHg and \\<32 mmHg at 2 consecutive visits (Eligibility 1 and Eligibility 2);\n* Previously prescribed TRAVATAN Z® 0.004%, XALATAN® 0.005%, or LUMIGAN® 0.01% monotherapy for at least 28 days prior to the Screening Visit;\n* Able to understand and sign Informed Consent Document;\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Women of childbearing potential who are pregnant, breastfeeding, or do not agree to use an adequate birth control method throughout the study;\n* Any form of glaucoma other than open angle glaucoma or ocular hypertension;\n* Severe central visual field loss;\n* Chronic, recurrent, or severe inflammatory eye disease;\n* Ocular trauma within the past 6 months;\n* Ocular infection or ocular inflammation within the past 3 months;\n* Best-corrected visual acuity score worse than approximately 20/80 Snellen;\n* Eye surgery within the past 6 months;\n* Any condition, including severe illness, which would make the subject unsuitable for the study in the opinion of the Investigator;\n* Use of any additional topical or systemic ocular hypertensive medication during the study;\n* Patients who, in the opinion of the Investigator, cannot discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to Eligibility 1 Visit;\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01937312', 'briefTitle': 'Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Additive Effect of Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as Adjunctive Therapy to a Prostaglandin Analogue', 'orgStudyIdInfo': {'id': 'M-13-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SIMBRINZA', 'description': 'Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks', 'interventionNames': ['Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension', 'Drug: Prostaglandin analogue']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Inactive ingredients, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks', 'interventionNames': ['Drug: Vehicle', 'Drug: Prostaglandin analogue']}], 'interventions': [{'name': 'Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension', 'type': 'DRUG', 'otherNames': ['SIMBRINZA® Suspension'], 'armGroupLabels': ['SIMBRINZA']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'Inactive ingredients used as a placebo comparator', 'armGroupLabels': ['Vehicle']}, {'name': 'Prostaglandin analogue', 'type': 'DRUG', 'otherNames': ['TRAVATAN Z®', 'LUMIGAN®', 'XALATAN®'], 'armGroupLabels': ['SIMBRINZA', 'Vehicle']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Steve Burmaster, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}