Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2025-12-29 @ 1:00 PM
Study NCT ID:
NCT01151904
Status:
TERMINATED
Last Update Posted:
2013-02-06
First Post:
2010-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015812', 'term': 'Glaucoma, Angle-Closure'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068438', 'term': 'Brimonidine Tartrate'}, {'id': 'D013999', 'term': 'Timolol'}, {'id': 'D000068599', 'term': 'Brimonidine Tartrate, Timolol Maleate Drug Combination'}, {'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': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': '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}, 'limitationsAndCaveats': {'description': 'Due to lack of enrollment, this study was discontinued early and the outcome measures were not analyzed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'COMBIGAN® With Latanoprost', 'description': 'Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.', 'otherNumAtRisk': 17, 'otherNumAffected': 5, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Corneal Erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival Hyperemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Intraocular Pressure (IOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COMBIGAN® With Latanoprost', 'description': 'Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.'}], 'timeFrame': 'Baseline, Week 12', 'description': 'IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.', 'reportingStatus': 'POSTED', 'populationDescription': 'Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IOP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COMBIGAN® With Latanoprost', 'description': 'Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.'}], 'timeFrame': 'Baseline, Week 2, Week 6', 'description': 'IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.', 'reportingStatus': 'POSTED', 'populationDescription': 'Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders With an IOP Reduction ≥20% From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COMBIGAN® With Latanoprost', 'description': 'Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.'}], 'timeFrame': 'Baseline, Week 12', 'description': 'IOP is a measure of the fluid pressure inside the eye. A responder is defined as a patient with a mean IOP reduction of at least 20% in the affected eye(s) from baseline. Due to lack of enrollment, analysis was not performed for this outcome measure.', 'reportingStatus': 'POSTED', 'populationDescription': 'Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'COMBIGAN® With Latanoprost', 'description': 'Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Due to lack of enrollment, this study was discontinued early.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'COMBIGAN® With Latanoprost', 'description': 'Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<45 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Between 45 and 65 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': '>65 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Difficulty with patient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-03', 'studyFirstSubmitDate': '2010-06-05', 'resultsFirstSubmitDate': '2013-01-03', 'studyFirstSubmitQcDate': '2010-06-28', 'lastUpdatePostDateStruct': {'date': '2013-02-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-03', 'studyFirstPostDateStruct': {'date': '2010-06-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Intraocular Pressure (IOP)', 'timeFrame': 'Baseline, Week 12', 'description': 'IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in IOP', 'timeFrame': 'Baseline, Week 2, Week 6', 'description': 'IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.'}, {'measure': 'Percentage of Responders With an IOP Reduction ≥20% From Baseline', 'timeFrame': 'Baseline, Week 12', 'description': 'IOP is a measure of the fluid pressure inside the eye. A responder is defined as a patient with a mean IOP reduction of at least 20% in the affected eye(s) from baseline. Due to lack of enrollment, analysis was not performed for this outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma, Angle-Closure']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of patients switched from latanoprost monotherapy to a combination therapy of latanoprost with COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) for chronic angle closure glaucoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has been administering latanoprost eye drops in affected eye(s) for at least 12 weeks prior to study\n* Patient must have at least partially responded to latanoprost and requiring further IOP lowering eye drops\n* Diagnosis of chronic angle-closure glaucoma\n* Patients using COMBIGAN® in the past must not have been discontinued due to adverse events or lack of efficacy.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to COMBIGAN®\n* Corneal abnormalities that would preclude accurate IOP readings\n* Any other active ocular disease other than glaucoma or ocular hypertension\n* Ocular surgery within the past 3 months.'}, 'identificationModule': {'nctId': 'NCT01151904', 'briefTitle': 'Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'MA-COM004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COMBIGAN® with Latanoprost', 'description': 'Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.', 'interventionNames': ['Drug: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution', 'Drug: latanoprost']}], 'interventions': [{'name': 'brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution', 'type': 'DRUG', 'otherNames': ['COMBIGAN®'], 'description': 'COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) administered as one drop in the morning and one drop in the evening in affected eye(s) for 12 weeks.', 'armGroupLabels': ['COMBIGAN® with Latanoprost']}, {'name': 'latanoprost', 'type': 'DRUG', 'description': 'Latanoprost administered in the affected eye(s) as prescribed by physician.', 'armGroupLabels': ['COMBIGAN® with Latanoprost']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'country': 'Thailand', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}