Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma; Ocular Hypertension
Intervention: 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution (Drug); Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution (Drug); Brimonidine 0.2% ophthalmic solution (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Allergan Official(s) and/or principal investigator(s): Medical Director, Study Director, Affiliation: Allergan
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
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Intraocular pressure (IOP)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
El Paso, Texas, United States
Additional Information
Link to Clinical Trial Results
Starting date: June 2003
Last updated: April 1, 2008
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