24-hr Intraocular Pressure Control With SIMBRINZA ®

Study Overview
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Brief Summary
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The purpose of this study is to evaluate differences between treatments in mean change from baseline in 24-hr intraocular pressure (IOP) at Week 4.

Detailed Description
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Subjects will undergo washout of pre-study IOP-lowering medications for the appropriate duration, then undergo 2 eligibility visits. Eligible subjects will be randomized 1:1, to receive masked SIMBRINZA ® or Vehicle for 4 weeks. Two 24-hour visits will be conducted (Day 0 and Week 4) during which intraocular pressure will be collected every 2 hours. The expected duration of subject participation in the study is 10 weeks.

Official Title
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24-hr Intraocular Pressure Control With Brinzolamide 1% / Brimonidine 0.2% Ophthalmic Suspension vs Vehicle

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of either open-angle glaucoma or ocular hypertension; Able to attend all study related visits and be housed overnight at clinical site for the study assessments; Willing and able to sign an informed consent form; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Women of childbearing potential who are pregnant, intend to become pregnant during the study, breast-feeding, or not using adequate birth control; Diagnosed with any form of glaucoma other than open angle glaucoma or ocular hypertension; Ocular surgeries or procedures excluded by the protocol; Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol; Best-corrected visual acuity score less than 55 ETDRS letters (equivalent to approximately 20/80 Snellen) in either eye; Other protocol-specific 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIMBRINZA<br>Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days | Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension<br> <br> * Other names: SIMBRINZA ®;|
| Active Comparator: Vehicle<br>Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days | Drug: Vehicle<br>* Inactive ingredients used as a placebo for masking purposes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4 | IOP (fluid pressure inside the eye) was measured in millimeters of mercury (mmHg). Change was calculated by taking the change from baseline at each time point and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis. | Baseline (Day 0), Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Squares Mean Change From Baseline in Daytime IOP at Week 4 | IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (8 AM through 8 PM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis. | Baseline (Day 0), Week 4 | 
| Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4 | IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (10 PM through 6 AM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis. | Baseline (Day 0), Week 4 | 
| Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | IOP (fluid pressure inside the eye) was measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis. | Baseline (Day 0), Week 4 |