Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-29 @ 7:07 AM
Study NCT ID:
NCT01243567
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2010-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069580', 'term': 'Bimatoprost'}, {'id': 'D013999', 'term': 'Timolol'}, {'id': 'C571755', 'term': 'Ganfort'}, {'id': 'D000077338', 'term': 'Latanoprost'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}], 'ancestors': [{'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003008', 'term': 'Cloprostenol'}, {'id': 'D011461', 'term': 'Prostaglandins F, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'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': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Vice President Medical Affairs,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution', 'description': 'Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.', 'otherNumAtRisk': 43, 'otherNumAffected': 9, 'seriousNumAtRisk': 43, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Latanoprost 0.005% Ophthalmic Solution', 'description': 'Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.', 'otherNumAtRisk': 38, 'otherNumAffected': 10, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ocular Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1'}, {'term': 'Conjunctival Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1'}, {'term': 'Foreign Body Sensation in Eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1'}], 'seriousEvents': [{'term': 'Colon Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Average Intraocular Pressure (IOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution', 'description': 'Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.'}, {'id': 'OG001', 'title': 'Latanoprost 0.005% Ophthalmic Solution', 'description': 'Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '28.4', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '28.5', 'spread': '2.57', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Month 3', 'categories': [{'measurements': [{'value': '-13.5', 'spread': '4.48', 'groupId': 'OG000'}, {'value': '-11.4', 'spread': '3.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).', 'unitOfMeasure': 'Millimeters of Mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat: all randomized patients.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline IOP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution', 'description': 'Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.'}, {'id': 'OG001', 'title': 'Latanoprost 0.005% Ophthalmic Solution', 'description': 'Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.'}], 'classes': [{'title': 'Baseline-08:00', 'categories': [{'measurements': [{'value': '29.7', 'spread': '2.97', 'groupId': 'OG000'}, {'value': '29.6', 'spread': '2.93', 'groupId': 'OG001'}]}]}, {'title': 'Baseline-12:00', 'categories': [{'measurements': [{'value': '28.7', 'spread': '4.46', 'groupId': 'OG000'}, {'value': '29.0', 'spread': '2.60', 'groupId': 'OG001'}]}]}, {'title': 'Baseline-16:00', 'categories': [{'measurements': [{'value': '26.8', 'spread': '4.01', 'groupId': 'OG000'}, {'value': '26.8', 'spread': '3.73', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Month 3-08:00', 'categories': [{'measurements': [{'value': '-14.6', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '-12.3', 'spread': '3.64', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Month 3-12:00', 'categories': [{'measurements': [{'value': '-13.6', 'spread': '5.50', 'groupId': 'OG000'}, {'value': '-11.8', 'spread': '3.14', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Month 3-16:00', 'categories': [{'measurements': [{'value': '-12.4', 'spread': '5.16', 'groupId': 'OG000'}, {'value': '-10.3', 'spread': '4.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. IOP is recorded at the 08:00 (8:00 am), 12:00 (noon) and 16:00 (4:00 pm) hour time points for each patient at each visit. A negative number change from Baseline indicates a reduction in IOP (improvement).', 'unitOfMeasure': 'Millimeters of Mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat: all randomized patients.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Reaching a Predefined Target Pressure Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution', 'description': 'Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.'}, {'id': 'OG001', 'title': 'Latanoprost 0.005% Ophthalmic Solution', 'description': 'Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.'}], 'classes': [{'title': 'Decrease of at Least 20%', 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Decrease of at Least 30%', 'categories': [{'measurements': [{'value': '90.7', 'groupId': 'OG000'}, {'value': '86.8', 'groupId': 'OG001'}]}]}, {'title': 'Decrease of at Least 40%', 'categories': [{'measurements': [{'value': '74.4', 'groupId': 'OG000'}, {'value': '47.4', 'groupId': 'OG001'}]}]}, {'title': 'Decrease of at Least 50%', 'categories': [{'measurements': [{'value': '46.5', 'groupId': 'OG000'}, {'value': '15.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 3', 'description': 'IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The predefined target pressure thresholds are at least a 20%, 30%, 40%, and 50% reduction in IOP from baseline.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat: all randomized patients.'}, {'type': 'SECONDARY', 'title': "Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading", 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution', 'description': 'Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.'}, {'id': 'OG001', 'title': 'Latanoprost 0.005% Ophthalmic Solution', 'description': 'Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '30.4', 'spread': '3.19', 'groupId': 'OG000'}, {'value': '30.3', 'spread': '2.54', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Difference at Month 3', 'categories': [{'measurements': [{'value': '-15.3', 'spread': '4.44', 'groupId': 'OG000'}, {'value': '-12.9', 'spread': '3.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The highest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.', 'unitOfMeasure': 'Millimeters of Mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat: all randomized patients.'}, {'type': 'SECONDARY', 'title': "Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading", 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution', 'description': 'Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.'}, {'id': 'OG001', 'title': 'Latanoprost 0.005% Ophthalmic Solution', 'description': 'Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '26.2', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '26.5', 'spread': '3.44', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Difference at Month 3', 'categories': [{'measurements': [{'value': '-11.8', 'spread': '5.23', 'groupId': 'OG000'}, {'value': '-9.9', 'spread': '3.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The lowest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.', 'unitOfMeasure': 'Millimeters of Mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat: all randomized patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution', 'description': 'Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.'}, {'id': 'FG001', 'title': 'Latanoprost 0.005% Ophthalmic Solution', 'description': 'Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution', 'description': 'Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.'}, {'id': 'BG001', 'title': 'Latanoprost 0.005% Ophthalmic Solution', 'description': 'Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.9', 'spread': '10.24', 'groupId': 'BG000'}, {'value': '63.1', 'spread': '13.72', 'groupId': 'BG001'}, {'value': '64.6', 'spread': '12.01', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2012-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-09', 'studyFirstSubmitDate': '2010-11-17', 'resultsFirstSubmitDate': '2013-01-22', 'studyFirstSubmitQcDate': '2010-11-17', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-01-22', 'studyFirstPostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Average Intraocular Pressure (IOP)', 'timeFrame': 'Baseline, Month 3', 'description': 'IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline IOP', 'timeFrame': 'Baseline, Month 3', 'description': 'IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. IOP is recorded at the 08:00 (8:00 am), 12:00 (noon) and 16:00 (4:00 pm) hour time points for each patient at each visit. A negative number change from Baseline indicates a reduction in IOP (improvement).'}, {'measure': 'Percentage of Patients Reaching a Predefined Target Pressure Threshold', 'timeFrame': 'Baseline, Month 3', 'description': 'IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The predefined target pressure thresholds are at least a 20%, 30%, 40%, and 50% reduction in IOP from baseline.'}, {'measure': "Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading", 'timeFrame': 'Baseline, Month 3', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The highest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.'}, {'measure': "Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading", 'timeFrame': 'Baseline, Month 3', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The lowest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma, Open-Angle']}, 'referencesModule': {'references': [{'pmid': '24748767', 'type': 'BACKGROUND', 'citation': 'Gutierrez-Diaz E, Silva Cotta J, Munoz-Negrete FJ, Gutierrez-Ortiz C, Morgan-Warren RJ, Maltman J. Bimatoprost/timolol fixed combination versus latanoprost in treatment-naive glaucoma patients at high risk of progression: a pilot study. Clin Ophthalmol. 2014 Apr 10;8:725-32. doi: 10.2147/OPTH.S56735. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never been previously treated and are at high risk for progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of primary open-angle glaucoma that has never been treated\n* Visual Acuity 20/60 or better in each eye\n\nExclusion Criteria:\n\n* Eye surgery within 3 months\n* Any refractive eye surgery\n* Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive pulmonary disease \\[COPD\\], bronchial asthma, sinus bradycardia, heart block, history of severe myocardial infarction \\[heart attack\\])\n* Eye inflammation or eye infection within 3 months\n* Eye trauma within 6 months\n* Oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use during study'}, 'identificationModule': {'nctId': 'NCT01243567', 'briefTitle': 'Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'MAF-AGN-OPH-GLA-010'}, 'secondaryIdInfos': [{'id': '2009-012799-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution', 'description': 'Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.', 'interventionNames': ['Drug: bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'latanoprost 0.005% ophthalmic solution', 'description': 'Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.', 'interventionNames': ['Drug: latanoprost 0.005% ophthalmic solution']}], 'interventions': [{'name': 'bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution', 'type': 'DRUG', 'otherNames': ['GANFort®'], 'description': 'Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.', 'armGroupLabels': ['bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution']}, {'name': 'latanoprost 0.005% ophthalmic solution', 'type': 'DRUG', 'otherNames': ['Xalatan®'], 'description': 'Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.', 'armGroupLabels': ['latanoprost 0.005% ophthalmic solution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Coimbra', 'country': 'Portugal', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}