Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-01-03 @ 10:20 PM
Study NCT ID:
NCT00651859
Status:
COMPLETED
Last Update Posted:
2008-04-03
First Post:
2008-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Bimatoprost in Ethnically Japanese Patients With Open-Angle Glaucoma or Ocular Hypertension
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': 'D000069580', 'term': 'Bimatoprost'}, {'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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2004-01', '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': '2004-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular pressure (IOP)', 'timeFrame': 'Day 14'}], 'secondaryOutcomes': [{'measure': 'IOP', 'timeFrame': 'Days 2 and 7'}]}, '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 and efficacy of once-daily bimatoprost 0.03% and 0.01% ophthalmic solutions compared with once-daily administered bimatoprost vehicle ophthalmic solution for 2 weeks in ethnically Japanese patients with open-angle glaucoma or ocular hypertension'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ethnically Japanese patients with glaucoma or ocular hypertension in each eye who require IOP-lowering therapy in both eyes\n\nExclusion Criteria:\n\n* Uncontrolled systemic disease\n* Use of bimatoprost or an ocular prostaglandin (eg, latanoprost, travoprost) within 6 weeks prior to baseline (Day 0)'}, 'identificationModule': {'nctId': 'NCT00651859', 'briefTitle': 'Safety and Efficacy Study of Bimatoprost in Ethnically Japanese Patients With Open-Angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '192024-024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Bimatoprost 0.01% Ophthalmic Solution', 'interventionNames': ['Drug: Bimatoprost 0.01% Ophthalmic Solution']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Bimatoprost 0.03% Ophthalmic Solution', 'interventionNames': ['Drug: Bimatoprost 0.03% Ophthalmic Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Bimatoprost Vehicle Ophthalmic Solution', 'interventionNames': ['Drug: Bimatoprost Vehicle Ophthalmic Solution']}], 'interventions': [{'name': 'Bimatoprost 0.01% Ophthalmic Solution', 'type': 'DRUG', 'description': 'Bimatoprost 0.01% ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00', 'armGroupLabels': ['1']}, {'name': 'Bimatoprost 0.03% Ophthalmic Solution', 'type': 'DRUG', 'otherNames': ['LUMIGAN®'], 'description': 'Bimatoprost 0.03% ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00', 'armGroupLabels': ['2']}, {'name': 'Bimatoprost Vehicle Ophthalmic Solution', 'type': 'DRUG', 'description': 'Bimatoprost vehicle ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Therapeutic Area Head', 'oldOrganization': 'Allergan, Inc.'}}}}