Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the safety and efficacy of a new ophthalmic suspension (Brinz/Brim) in lowering intraocular pressure (IOP) relative to its individual active components in subjects with open-angle glaucoma and/or ocular hypertension.

Detailed Description
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This study consisted of 7 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and the treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 3 study drug groups. The study was designed to evaluate the efficacy and safety of Brinzolamide/Brimonidine over a 3-month period, with an additional 3 months of study drug exposure intended to provide further safety data.

Official Title
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A Three-Month, Randomized, Double-Masked, Parallel-Group Study With a Planned Three-Month Safety Extension of the Efficacy and Safety of a Fixed Combination of Brinzolamide 1%/Brimonidine 0.2% Compared to Brinzolamide 1% and Brimonidine 0.2% All Dosed Three Times Daily in Patients With Open-Angle Glaucoma and/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, with mean intraocular pressure within protocol-specified range at eligibility visit/s. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures. Any form of glaucoma other than open-angle glaucoma. Severe central vision loss in either eye. Chronic, recurrent, or severe inflammatory eye disease. Ocular trauma within the preceding 6 months. Ocular infection or ocular inflammation within the preceding 3 months. Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment. Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart. Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product. Ocular surgery within the preceding 6 months. Ocular laser surgery within the preceding 3 months. Any abnormality preventing reliable applanation tonometry. Any other conditions, including severe illness, which could make the subject, in the opinion of the Investigator, unsuitable for the study. Other protocol-specified 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: Quadruple


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 eye 3 times a day for 3 months | Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension<br> <br> |
| Active Comparator: Brinzolamide<br>Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months | Drug: Brinzolamide ophthalmic suspension, 1%<br> <br> |
| Active Comparator: Brimonidine<br>Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months | 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 Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3 | The study drug was instilled at 8 AM and 3 PM (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). | Month 3 | 

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