Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT00314158
Status:
COMPLETED
Last Update Posted:
2016-11-18
First Post:
2006-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C111827', 'term': 'brinzolamide'}, {'id': 'D013999', 'term': 'Timolol'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}, {'id': 'D013535', 'term': 'Suspensions'}, {'id': 'D012996', 'term': 'Solutions'}], 'ancestors': [{'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': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D019999', 'term': 'Pharmaceutical 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'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 523}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-17', 'studyFirstSubmitDate': '2006-04-10', 'studyFirstSubmitQcDate': '2006-04-12', 'lastUpdatePostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean intra-ocular pressure (IOP)'}]}, 'conditionsModule': {'conditions': ['Open-angle Glaucoma', 'Ocular Hypertension']}, 'referencesModule': {'references': [{'pmid': '18538406', 'type': 'RESULT', 'citation': 'Kaback M, Scoper SV, Arzeno G, James JE, Hua SY, Salem C, Dickerson JE, Landry TA, Bergamini MV; Brinzolamide 1%/Timolol 0.5% Study Group. Intraocular pressure-lowering efficacy of brinzolamide 1%/timolol 0.5% fixed combination compared with brinzolamide 1% and timolol 0.5%. Ophthalmology. 2008 Oct;115(10):1728-34, 1734.e1-2. doi: 10.1016/j.ophtha.2008.04.011. Epub 2008 Jun 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Diagnosis of open-angle glaucoma\n* Other protocol-defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* Under 18\n* Pregnant\n* Other protocol-defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00314158', 'briefTitle': 'A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'C-05-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brinzolamide +Timolol', 'interventionNames': ['Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brinzolamide', 'interventionNames': ['Drug: Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Timolol', 'interventionNames': ['Drug: Timolol 5 mg/ml eye drops, solution']}], 'interventions': [{'name': 'Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension', 'type': 'DRUG', 'description': 'One drop twice daily in each study eye for six months', 'armGroupLabels': ['Brinzolamide +Timolol']}, {'name': 'Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension', 'type': 'DRUG', 'otherNames': ['AZOPT'], 'description': 'One drop twice daily in each study eye for six months', 'armGroupLabels': ['Brinzolamide']}, {'name': 'Timolol 5 mg/ml eye drops, solution', 'type': 'DRUG', 'description': 'One drop twice daily in each study eye for six months', 'armGroupLabels': ['Timolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'United States Investigative Sites', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}