Comparison of the Efficacy of AZARGA® Versus COSOPT® in Patients With Open-Angled Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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Subjects are dosed twice daily at 9AM and 9PM for 12 weeks. The primary efficacy variable is the mean change in Intraocular Pressure (IOP) from baseline to 12 weeks. Secondary efficacy variable: % IOP ≤ 18 millimeters mercury (mmHg). Exploratory endpoint: Ocular discomfort scale after first dose.

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Azarga (brinzolamide 1% / timolol 0.5%)
* Drug: Cosopt (dorzolamide 2% / timolol 0.5%)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be at least 18 years of age. Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in at least one eye (study eye). Must have 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 study period. Must be willing to discontinue the use of all other ocular hypotensive agents prior to receiving the assigned study drug at Visit 1, throughout the study period. Must have an IOP of between 19 to 35 mmHg in at least one eye (which would be the study eye). For the eyes not included in the study, the intraocular pressure should be able to be controlled on no pharmacologic therapy or on the study medicine alone. Exclusion Criteria: Known medical history of allergy, hypersensitivity or poor tolerance to any components of the preparations to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator. Presence of other primary or secondary glaucoma not listed in inclusion criterion #2. Any abnormality preventing reliable applanation tonometry in study eye(s). Risk of visual field or visual acuity worsening due to participation in the study, in the investigator's best judgment. Progressive retinal or optic nerve disease from any cause. Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Day 1 Visit or an anticipated change in the dosage during the course of the study. A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject. Participation in any other investigational study within 30 days prior to Visit 1.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azarga<br>Azarga (brinzolamide 1% / timolol 0.5%) | Drug: Azarga (brinzolamide 1% / timolol 0.5%)<br>* Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks<br>|
| Active Comparator: Cosopt<br>Cosopt (dorzolamide 2% / timolol 0.5%) | Drug: Cosopt (dorzolamide 2% / timolol 0.5%)<br>* Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Intraocular Pressure (IOP) following 12 weeks of twice daily dosing |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with IOP ≤ 18 millimeters mercury (mmHg) |  | 12 weeks |