AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure

Study Overview
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Brief Summary
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The purpose of this study was to assess the safety and efficacy of switching to Azarga from prior pharmacotherapy in patients with open-angle glaucoma.

Official Title
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Assessing the Safety and Efficacy of Switching to AZARGA® (Brinzolamide/Timolol Fixed Combination) as Replacement Therapy in Patients With Uncontrolled Intraocular Pressure in Taiwan

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Brinzolamide 1% and timolol 0.5% fixed combination eye drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes. Must be on a stable regimen of intra-ocular pressure (IOP) lowering medication within one week of screening/baseline visit. Must have an IOP of between 19 and 35 mmHg (both inclusive) in at least one eye, which would be the study eye, at screening. Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study. Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the medication to be used in the study deemed clinically significant in the opinion of the principal investigator. Any abnormality preventing reliable applanation tonometry in either eye. Risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment. Pregnant or lactating. Participation in any other investigational study within 30 days of screening visit. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 20 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: AZARGA<br>Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks. | Drug: Brinzolamide 1% and timolol 0.5% fixed combination eye drops<br> <br> * Other names: AZARGA®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only) | As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants. | Baseline, Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy | As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants. | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open-angle glaucoma, Ocular hypertension, Pigment dispersion glaucoma