Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients
This study evaluates the safety of brimonidine/timolol fixed combination in glaucoma or ocular hypertension...
Brief Summary
This study evaluates the safety of brimonidine/timolol fixed combination in glaucoma or ocular hypertension patients
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: January 2007
Intervention(s) in this Clinical Trial
- Drug: Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution
- Brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution 1 drop instilled in each eye two times daily (morning and evening)
- Drug: Concurrent brimonidine 0.2% and 0.5% timolol
- 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)
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution
- Active Comparator: 2
- Concurrent Brimonidine 0.2% and 0.5% Timolol
Outcome Measures for this Clinical Trial
Primary Measures
- Adverse Events
- Time Frame: Day 10
Safety Issue?: No
- Time Frame: Day 10
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Diagnosis of ocular hypertension or glaucoma
- Patient requires IOP-lowering therapy in both eyes
Exclusion Criteria:
- Uncontrolled medical conditions
- Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Allergan Industry
Overall Clinical Trial Officials and Contacts
Medical Director Study Director Allergan
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00651612
Study ID Number: 190342-024T
ClinicalTrials.gov Identifier: NCT00651612
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00651612
