Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of adding AZARGA in glaucoma patients with uncontrolled intraocular pressure (IOP), currently on prostaglandin monotherapy.

Official Title
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The Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (Azarga®) to Prostaglandin Monotherapy

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign Informed Consent. 21 years of age or older. Able to follow instructions and willing to attend required study visits. Clinical diagnosis of ocular hypertension, primary open-angle, or pigment dispersion glaucoma in at least one eye (qualifying eye). Intra-ocular pressure (IOP) considered to be safe in both eyes in such a way that should assure clinical stability of vision and the optic nerve throughout the trial. Must have best corrected visual acuity of 6/60 (6/60 Snellen, 1.0 LogMAR) or better in each eye. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Presence of other primary or secondary glaucomas not listed in inclusion criterion. Presence of corneal dystrophies. Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Intraocular conventional surgery or laser surgery in qualifying eye(s) less than three months prior to Visit 1. Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment. Women of childbearing potential not using reliable means of birth control. Women who are pregnant or lactating. Participation in any other investigational study within 30 days prior to Visit 1. Current or anticipated use of systemic corticosteroids, by any route except inhaled, for greater than two weeks during the trial. Severe allergic rhinitis History of ocular herpes simplex. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 21 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brinzolamide/Timolol Maleate Fixed Combination<br> | Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)<br>* 1 drop of study medication into the study eye(s) beginning the evening of Visit 1 and continuing twice daily (morning and evening) for 12 weeks<br>* Other names: AZARGA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean decrease in intraocular pressure (IOP) at 12 weeks from baseline |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as determined by visual acuity, biomicroscopy, adverse events, solicited symptom survey and treatment success |  | Week 4 and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IOP, Glaucoma, AZARGA