A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%

Study Overview
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Brief Summary
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The purpose of this study was to describe the ocular discomfort immediately upon instillation of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with open-angle glaucoma and/or ocular hypertension.

Official Title
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A Descriptive Comfort Study of Brinzolamide 1% / Brimonidine Tartrate 0.2% Fixed Combination Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension and Brimonidine Tartrate 0.2% Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension

Conditions
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Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
* Drug: Brinzolamide ophthalmic suspension, 1%
* Drug: Brimonidine tartrate ophthalmic solution, 0.2%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign Informed Consent document. Diagnosis of open-angle glaucoma or ocular hypertension Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures. Severe central vision loss in either eye. Any chronic or recurrent inflammatory eye disease. Ocular trauma within the preceding 6 months. Ocular infection or ocular inflammation within the preceding 3 months. Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart. Any intraocular surgery within the preceding 6 months. Any ocular laser surgery within the preceding 3 months. History or current evidence of severe illness or any other conditions which would make the subject, in the opinion of the Investigator, unsuitable for the study. Other protocol-defined exclusion criteria may apply.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brinz/Brim<br>Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days | Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension<br> <br> |
| Active Comparator: Brinzolamide<br>Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days | Drug: Brinzolamide ophthalmic suspension, 1%<br> <br> |
| Active Comparator: Brimonidine<br>Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days | Drug: Brimonidine tartrate ophthalmic solution, 0.2%<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Ocular Discomfort Score | Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe). | Week 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open-Angle Glaucoma, Ocular Hypertension, Intraocular Pressure, Brinzolamide, Brimonidine