Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
This study evaluates the safety and efficacy of brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol ophthalmic...
Brief Summary
This study evaluates the safety and efficacy of brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol ophthalmic solutions
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: March 2004
Intervention(s) in this Clinical Trial
- Drug: 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
- 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
- Drug: Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
- Brimonidine 0.2% 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and concurrent timolol 0.5% ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
- Drug: Brimonidine 0.2% ophthalmic solution
- Brimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and evening)
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
- Active Comparator: 2
- Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
- Active Comparator: 3
- 0.2% brimonidine ophthalmic solution
Outcome Measures for this Clinical Trial
Primary Measures
- Intraocular pressure (IOP)
- Time Frame: Day 28
Safety Issue?: No
- Time Frame: Day 28
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/NCT00652106
Study ID Number: 190342-019T
ClinicalTrials.gov Identifier: NCT00652106
Health Authority: United States: Food and Drug Administration
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00652106
