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

Phase 4TerminatedNCT01151904

Allergan17 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma, Angle-Closure

Interventions

brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solutionDRUG

COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) administered as one drop in the morning and one drop in the evening in affected eye(s) for 12 weeks.

latanoprostDRUG

Latanoprost administered in the affected eye(s) as prescribed by physician.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Bangkok, Thailand

Outcomes

Primary Outcomes

Change From Baseline in Intraocular Pressure (IOP)

IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.

Time frame: Baseline, Week 12

Secondary Outcomes

Change From Baseline in IOP

Time frame: Baseline, Week 2, Week 6

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

IOP is a measure of the fluid pressure inside the eye. A responder is defined as a patient with a mean IOP reduction of at least 20% in the affected eye(s) from baseline. Due to lack of enrollment, analysis was not performed for this outcome measure.

Time frame: Baseline, Week 12

Data from ClinicalTrials.gov

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