Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients

Phase 3

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution; Drug: Concurrent brimonidine 0.2% and 0.5% timolol

• Registration Number: NCT00651612
• Lead Sponsor: Allergan

Brief Summary

This study evaluates the safety of brimonidine/timolol fixed combination in glaucoma or ocular hypertension patients

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2008-04
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-01
• Last Update Submitted: 2008-04-01
• Study First Posted: 2008-04-03
• Last Update Posted: 2008-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 604

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution	Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution
2	Concurrent brimonidine 0.2% and 0.5% timolol	Concurrent Brimonidine 0.2% and 0.5% Timolol

Primary Outcome Measures

Name	Time	Method
Adverse Events	Day 10