Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT00651612
Status:
COMPLETED
Last Update Posted:
2008-04-03
First Post:
2008-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 604}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-01', 'studyFirstSubmitDate': '2008-04-01', 'studyFirstSubmitQcDate': '2008-04-01', 'lastUpdatePostDateStruct': {'date': '2008-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Day 10'}]}, 'conditionsModule': {'conditions': ['Glaucoma', 'Ocular Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.allerganclinicaltrials.com', 'label': 'Link to Clinical Trial Results'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety of brimonidine/timolol fixed combination in glaucoma or ocular hypertension patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ocular hypertension or glaucoma\n* Patient requires IOP-lowering therapy in both eyes\n\nExclusion Criteria:\n\n* Uncontrolled medical conditions\n* Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy'}, 'identificationModule': {'nctId': 'NCT00651612', 'briefTitle': 'Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '190342-024T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution', 'interventionNames': ['Drug: Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Concurrent Brimonidine 0.2% and 0.5% Timolol', 'interventionNames': ['Drug: Concurrent brimonidine 0.2% and 0.5% timolol']}], 'interventions': [{'name': 'Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution', 'type': 'DRUG', 'otherNames': ['COMBIGAN™'], 'description': 'Brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution 1 drop instilled in each eye two times daily (morning and evening)', 'armGroupLabels': ['1']}, {'name': 'Concurrent brimonidine 0.2% and 0.5% timolol', 'type': 'DRUG', 'description': 'Brimonidine 0.2%, 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and timolol 0.5% timolol, 1 drop instilled in each eye twice daily (morning and evening) and vehicle of brimonidine combination ophthalmic solution 1 drop instilled in each eye (morning, afternoon and/or evening)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Therapeutic Area Head', 'oldOrganization': 'Allergan'}}}}