Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-02-03 @ 3:07 AM
Study NCT ID:
NCT02140060
Status:
COMPLETED
Last Update Posted:
2015-12-29
First Post:
2014-05-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C111827', 'term': 'brinzolamide'}, {'id': 'D000069557', 'term': 'Travoprost'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Clinical Project Lead, GCRA, Pharma', '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 a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent.", '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. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.', 'eventGroups': [{'id': 'EG000', 'title': 'TravA/Brinz', 'description': 'Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks', 'otherNumAtRisk': 44, 'otherNumAffected': 7, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TravB/Brinz', 'description': 'Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks', 'otherNumAtRisk': 44, 'otherNumAffected': 11, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'TravC/Brinz', 'description': 'Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks', 'otherNumAtRisk': 44, 'otherNumAffected': 15, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'TRAV Z', 'description': 'Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks', 'otherNumAtRisk': 45, 'otherNumAffected': 10, 'seriousNumAtRisk': 45, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'AZOPT', 'description': 'Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks', 'otherNumAtRisk': 45, 'otherNumAffected': 9, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'TRAV Z + AZOPT', 'description': 'Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks', 'otherNumAtRisk': 44, 'otherNumAffected': 13, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Pre-treatment', 'description': 'All subjects who signed an informed consent to participate in the study', 'otherNumAtRisk': 327, 'otherNumAffected': 1, 'seriousNumAtRisk': 327, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 327, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 327, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 327, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 327, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 327, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 327, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 327, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean IOP at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'TravA/Brinz', 'description': 'Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks'}, {'id': 'OG001', 'title': 'TravB/Brinz', 'description': 'Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks'}, {'id': 'OG002', 'title': 'TravC/Brinz', 'description': 'Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks'}, {'id': 'OG003', 'title': 'TRAV Z', 'description': 'Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks'}, {'id': 'OG004', 'title': 'AZOPT', 'description': 'Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks'}, {'id': 'OG005', 'title': 'TRAV Z + AZOPT', 'description': 'Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks'}], 'classes': [{'title': '8 AM', 'categories': [{'measurements': [{'value': '20.2', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '19.9', 'spread': '0.58', 'groupId': 'OG002'}, {'value': '19.3', 'spread': '0.48', 'groupId': 'OG003'}, {'value': '22.0', 'spread': '0.45', 'groupId': 'OG004'}, {'value': '20.3', 'spread': '0.72', 'groupId': 'OG005'}]}]}, {'title': '10 AM', 'categories': [{'measurements': [{'value': '18.9', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '18.2', 'spread': '0.55', 'groupId': 'OG002'}, {'value': '17.4', 'spread': '0.47', 'groupId': 'OG003'}, {'value': '19.7', 'spread': '0.50', 'groupId': 'OG004'}, {'value': '18.2', 'spread': '0.59', 'groupId': 'OG005'}]}]}, {'title': '12 PM', 'categories': [{'measurements': [{'value': '18.9', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '17.7', 'spread': '0.51', 'groupId': 'OG002'}, {'value': '17.2', 'spread': '0.50', 'groupId': 'OG003'}, {'value': '19.5', 'spread': '0.53', 'groupId': 'OG004'}, {'value': '18.0', 'spread': '0.57', 'groupId': 'OG005'}]}]}, {'title': '4PM', 'categories': [{'measurements': [{'value': '18.5', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '17.3', 'spread': '0.46', 'groupId': 'OG002'}, {'value': '17.6', 'spread': '0.44', 'groupId': 'OG003'}, {'value': '19.1', 'spread': '0.50', 'groupId': 'OG004'}, {'value': '18.0', 'spread': '0.52', 'groupId': 'OG005'}]}]}, {'title': '8 PM, n=44, 44, 44, 43, 45, 43', 'categories': [{'measurements': [{'value': '18.4', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '17.2', 'spread': '0.40', 'groupId': 'OG002'}, {'value': '17.3', 'spread': '0.43', 'groupId': 'OG003'}, {'value': '19.3', 'spread': '0.48', 'groupId': 'OG004'}, {'value': '18.1', 'spread': '0.49', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM', 'description': 'IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) was used for the analysis.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all subjects who were randomized, received study medication, and completed at least 1 scheduled on-therapy study visit, based upon a last on-therapy carried forward (LOCF) analysis. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TravA/Brinz', 'description': 'Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks'}, {'id': 'FG001', 'title': 'TravB/Brinz', 'description': 'Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks'}, {'id': 'FG002', 'title': 'TravC/Brinz', 'description': 'Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks'}, {'id': 'FG003', 'title': 'TRAV Z', 'description': 'Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks'}, {'id': 'FG004', 'title': 'AZOPT', 'description': 'Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks'}, {'id': 'FG005', 'title': 'TRAV Z + AZOPT', 'description': 'Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '44'}, {'groupId': 'FG003', 'numSubjects': '45'}, {'groupId': 'FG004', 'numSubjects': '45'}, {'groupId': 'FG005', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '44'}, {'groupId': 'FG003', 'numSubjects': '43'}, {'groupId': 'FG004', 'numSubjects': '44'}, {'groupId': 'FG005', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 19 study centers located in the US.', 'preAssignmentDetails': 'Of the 327 enrolled, 61 subjects were discontinued prior to randomization. This reporting group includes all randomized subjects (266).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}, {'value': '265', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'TravA/Brinz', 'description': 'Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks'}, {'id': 'BG001', 'title': 'TravB/Brinz', 'description': 'Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks'}, {'id': 'BG002', 'title': 'TravC/Brinz', 'description': 'Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks'}, {'id': 'BG003', 'title': 'TRAV Z', 'description': 'Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks'}, {'id': 'BG004', 'title': 'AZOPT', 'description': 'Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks'}, {'id': 'BG005', 'title': 'TRAV Z + AZOPT', 'description': 'Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.4', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '66.2', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '64.4', 'spread': '11.2', 'groupId': 'BG002'}, {'value': '64.2', 'spread': '10.4', 'groupId': 'BG003'}, {'value': '63.1', 'spread': '8.4', 'groupId': 'BG004'}, {'value': '65.3', 'spread': '10.6', 'groupId': 'BG005'}, {'value': '64.8', 'spread': '10.3', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '152', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '113', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all subjects who were randomized, received study medication, and completed at least 1 scheduled on-therapy study visit.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 327}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-24', 'studyFirstSubmitDate': '2014-05-14', 'resultsFirstSubmitDate': '2015-11-24', 'studyFirstSubmitQcDate': '2014-05-15', 'lastUpdatePostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-24', 'studyFirstPostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean IOP at Week 6', 'timeFrame': 'Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM', 'description': 'IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) was used for the analysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Ocular', 'Hypertension', 'OAG', 'POAG', 'OHT'], 'conditions': ['Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate Travoprost/Brinzolamide fixed combination (Trav/Brinz) administered twice daily as compared to each of its marketed components (TRAVATAN Z® solution and AZOPT® suspension) and to the unfixed combination of TRAVATAN Z® plus AZOPT® in lowering intraocular pressure (IOP).', 'detailedDescription': 'This study was divided into two phases conducted in sequence. Phase I was the Screening/Eligibility Phase, which included a Screening Visit, followed by two Eligibility Visits. Phase II was the randomized, double-masked, 6-week Treatment Phase which included on-therapy visits at Week 2 and Week 6. Travoprost was administered in 1 of 3 concentration levels (A-C), where A=lowest and C=highest.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;\n* IOP within the protocol-specified range at both the Eligibility 1 and 2 Visits. Mean IOP must not be \\>36 mmHg at any time point;\n* Able to understand and sign an informed consent form;\n* Other protocol-specified inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Woman of childbearing potential who is currently pregnant, intends to become pregnant during the study period, breastfeeding, or not using adequate birth control methods to prevent pregnancy throughout the study;\n* Unable to discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to the E1 Visit;\n* Chronic, recurrent or severe inflammatory eye disease;\n* Ocular trauma within the past 6 months prior to the Screening Visit;\n* Ocular infection or ocular inflammation within the past 3 months prior to the Screening Visit;\n* Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment;\n* Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal);\n* Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of a topical prostaglandin analogue or topical carbonic anhydrase inhibitor;\n* Intraocular surgery within the past 6 months prior to the Screening Visit;\n* Ocular laser surgery within the past 3 months prior to the Screening Visit;\n* Any abnormality preventing reliable applanation tonometry;\n* Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;\n* History of hepatic or renal disease that would preclude the safe administration of a carbonic anhydrase inhibitor (CAI) in the opinion of the Investigator;\n* Hypersensitivity to prostaglandin analogues, topical or oral CAIs, sulfonamide derivatives, or to any component of the study medications in the opinion of the Investigator;\n* Recent (within 4 weeks of the Eligibility 1 Visit) use of high dose (\\> 1 g daily) salicylate therapy;\n* Use of any additional topical or systemic ocular hypotensive medication during the study;\n* Concurrent use of glucocorticoids administered by any route;\n* Less than 30 days stable dosing regimen before the Screening Visit of any medications (excluding the IOP-lowering treatments) or substances administered by any route and used on a chronic basis that may affect IOP (ie, β adrenergic blocking agents);\n* Therapy with another investigational agent within 30 days prior to the Screening Visit;\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02140060', 'briefTitle': '6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'A 6-Week Proof-of-Concept Study Evaluating the Safety and IOP-Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': 'C-14-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TravA/Brinz', 'description': 'Dose Level A / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks', 'interventionNames': ['Drug: Dose Level A / Brinzolamide 1% ophthalmic suspension', 'Drug: Travoprost solution vehicle']}, {'type': 'EXPERIMENTAL', 'label': 'TravB/Brinz', 'description': 'Dose Level B / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks', 'interventionNames': ['Drug: Dose Level B / Brinzolamide 1% ophthalmic suspension', 'Drug: Travoprost solution vehicle']}, {'type': 'EXPERIMENTAL', 'label': 'TravC/Brinz', 'description': 'Dose Level C / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks', 'interventionNames': ['Drug: Dose Level C / Brinzolamide 1% ophthalmic suspension', 'Drug: Travoprost solution vehicle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AZOPT', 'description': 'Brinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks', 'interventionNames': ['Drug: Brinzolamide 1% ophthalmic suspension AZOPT®', 'Drug: Travoprost solution vehicle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TRAV Z', 'description': 'Brinzolamide suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks', 'interventionNames': ['Drug: Travoprost 0.004% ophthalmic solution TRAVATAN Z®', 'Drug: Brinzolamide suspension vehicle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TRAV Z + AZOPT', 'description': 'Brinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks', 'interventionNames': ['Drug: Brinzolamide 1% ophthalmic suspension AZOPT®', 'Drug: Travoprost 0.004% ophthalmic solution TRAVATAN Z®']}], 'interventions': [{'name': 'Dose Level A / Brinzolamide 1% ophthalmic suspension', 'type': 'DRUG', 'description': 'Fixed combination', 'armGroupLabels': ['TravA/Brinz']}, {'name': 'Dose Level B / Brinzolamide 1% ophthalmic suspension', 'type': 'DRUG', 'description': 'Fixed combination', 'armGroupLabels': ['TravB/Brinz']}, {'name': 'Dose Level C / Brinzolamide 1% ophthalmic suspension', 'type': 'DRUG', 'description': 'Fixed combination', 'armGroupLabels': ['TravC/Brinz']}, {'name': 'Brinzolamide 1% ophthalmic suspension AZOPT®', 'type': 'DRUG', 'otherNames': ['AZOPT®'], 'armGroupLabels': ['AZOPT', 'TRAV Z + AZOPT']}, {'name': 'Travoprost 0.004% ophthalmic solution TRAVATAN Z®', 'type': 'DRUG', 'otherNames': ['TRAVATAN Z®'], 'armGroupLabels': ['TRAV Z', 'TRAV Z + AZOPT']}, {'name': 'Travoprost solution vehicle', 'type': 'DRUG', 'description': 'Inactive ingredients used for masking purposes', 'armGroupLabels': ['AZOPT', 'TravA/Brinz', 'TravB/Brinz', 'TravC/Brinz']}, {'name': 'Brinzolamide suspension vehicle', 'type': 'DRUG', 'description': 'Inactive ingredients used for masking purposes', 'armGroupLabels': ['TRAV Z']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sr. Clinical Manager, GCRA, Pharma', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}