Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

Allergan432 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

432

Conditions

Glaucoma Ocular Hypertension

Interventions

0.2% brimonidine/0.5% timolol fixed combination ophthalmic solutionDRUG

0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)

Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solutionDRUG

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)

Brimonidine 0.2% ophthalmic solutionDRUG

Brimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and evening)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Unnamed facility

El Paso, Texas, United States

Outcomes

Primary Outcomes

Intraocular pressure (IOP)

Time frame: Day 28

Data from ClinicalTrials.gov

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