Brimonidine 0.1% Versus Brinzolamide 1% as Adjunctive Therapy to Latanoprost 0.005%

Phase 4

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: latanoprost 0.005% eye drops and brimonidine 0.1% eye drops; Drug: latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops

• Registration Number: NCT00440141
• Lead Sponsor: Allergan

Brief Summary

Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering will be randomized to receive either brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to latanoprost 0.005%

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2007-02-22
• Study First Submitted QC: 2007-02-22
• Study First Posted: 2007-02-26
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-26
• Last Update Posted: 2008-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Glaucoma or ocular hypertension in both eyes
• Currently being treated with latanoprost 0.005% QD
• IOP greater than or equal to 18mm Hg on latanoprost 0.005%
• Best-corrected VA of 20/200 or better in each eye
• Visual field within 6 months of study entry

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Exclusion Criteria

• Secondary glaucoma
• Active intraocular inflammation or macular edema
• Intraocular surgery or laser surgery within the past 3 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	latanoprost 0.005% eye drops and brimonidine 0.1% eye drops	-
2	latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops	-

Primary Outcome Measures

Name	Time	Method
IOP	Month 3

Secondary Outcome Measures

Name	Time	Method
Tolerability	Month 3