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

Study Overview
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Brief Summary
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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.

Conditions
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Glaucoma, Angle-Closure

Intervention / Treatment
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* Drug: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution
* Drug: latanoprost


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COMBIGAN® with Latanoprost<br>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. | Drug: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution<br>* 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.<br>* Other names: COMBIGAN®;Drug: latanoprost<br>* Latanoprost administered in the affected eye(s) as prescribed by physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 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. | 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. | Baseline, Week 12 |