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

Phase 3

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Brimonidine 0.2% ophthalmic solution; Drug: 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution; Drug: Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution

• Registration Number: NCT00652106
• Lead Sponsor: Allergan

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2004-03
• Study Completion: 2004-03
• 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: 432

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
3	Brimonidine 0.2% ophthalmic solution	0.2% brimonidine ophthalmic solution
1	0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution	0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
2	Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution	Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Intraocular pressure (IOP)	Day 28