Safety and Efficacy Study of Brimonidine in Patients With Glaucoma or Ocular Hypertension

Phase 3

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Brimonidine ophthalmic solution 0.1%; Drug: Brimonidine ophthalmic solution 0.2%

• Registration Number: NCT00652483
• Lead Sponsor: Allergan

Brief Summary

This study evaluates the safety and efficacy of brimonidine 0.1% ophthalmic solution compared with brimonidine 0.2% ophthalmic solution in patients with glaucoma or ocular hypertension

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2003-12
• Study Completion: 2004-09
• 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: 433

Inclusion Criteria

• Ocular hypertension or glaucoma in both eyes

Exclusion Criteria

• Uncontrolled systemic disease
• Known allergy or sensitivity to brimonidine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Brimonidine ophthalmic solution 0.1%	Brimonidine ophthalmic solution 0.1%
2	Brimonidine ophthalmic solution 0.2%	Brimonidine ophthalmic solution 0.2%

Primary Outcome Measures

Name	Time	Method
Intraocular pressure (IOP)	Week 2 - Month 3

Secondary Outcome Measures

Name	Time	Method
IOP	Month 6 - Month 12