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

Phase 4

Terminated

• Conditions: Glaucoma, Angle-Closure
• Interventions: Drug: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution; Drug: latanoprost

• Registration Number: NCT01151904
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-06-05
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2013-01
• Results First Submitted: 2013-01-03
• Results First Submitted QC: 2013-01-03
• Last Update Submitted: 2013-01-03
• Results First Posted: 2013-02-06
• Last Update Posted: 2013-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COMBIGAN® with Latanoprost	latanoprost	Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
COMBIGAN® with Latanoprost	brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution	Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Intraocular Pressure (IOP)	Baseline, Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in IOP	Baseline, Week 2, Week 6	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.
Percentage of Responders With an IOP Reduction ≥20% From Baseline	Baseline, Week 12	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.