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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

Page last updated: August 23, 2015

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