Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients

Condition(s) targeted: Glaucoma, Angle-Closure

Intervention: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution (Drug); latanoprost (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

This study will evaluate the safety and efficacy of patients switched from latanoprost monotherapy to a combination therapy of latanoprost with COMBIGAN® (brimonidine 0. 2%/timolol 0. 5% fixed combination ophthalmic solution) for chronic angle closure glaucoma.

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline in Intraocular Pressure (IOP)

Secondary outcome:

Change From Baseline in IOP

Percentage of Responders With an IOP Reduction ≥20% From Baseline

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient has been administering latanoprost eye drops in affected eye(s) for at least

12 weeks prior to study

- Patient must have at least partially responded to latanoprost and requiring further

IOP lowering eye drops

- Diagnosis of chronic angle-closure glaucoma

- Patients using COMBIGAN® in the past must not have been discontinued due to adverse

events or lack of efficacy. Exclusion Criteria:

- Known allergy or hypersensitivity to COMBIGAN®

- Corneal abnormalities that would preclude accurate IOP readings

- Any other active ocular disease other than glaucoma or ocular hypertension

- Ocular surgery within the past 3 months.

Bangkok, Thailand

Starting date: November 2009
Last updated: January 3, 2013