Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.

Detailed Description
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This study consisted of two phases, a Screening/Eligibility Phase and a Treatment Phase. Both phases required the patient to complete an overnight stay.

Official Title
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Prospective, Randomized, Single-Center Study to Evaluate 24-hour Intraocular Pressure Control With Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination Therapy

Conditions
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Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension
* Drug: Timolol Maleate 0.5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes. Willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments. Must sign an Informed Consent form. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Women of childbearing potential if pregnant, breastfeeding, or not using adequate birth control. Severe central visual field loss in either eye. Chronic, recurrent or severe inflammatory eye disease. Ocular trauma or ocular surgery within the past 6 months. Ocular infection or ocular inflammation within the past 3 months. Clinically significant or progressive retinal disease. Other ocular pathology, including severe dry eye, that may in the opinion of the investigator preclude the administration of study medication. Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study. Any medical condition that would preclude the safe administration of a topical beta-blocker. Cannot safely discontinue all glucocorticoids administered by any route. 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIMBRINZA™<br>Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension, 1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks | Drug: Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension<br>* Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.<br>* Other names: SIMBRINZA™;|
| Active Comparator: Timolol Maleate 0.5%<br>Timolol Maleate 0.5%, 1 drop twice a day (8AM, 8PM) in each eye for 4 weeks | Drug: Timolol Maleate 0.5%<br>* Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.<br>* Other names: ISTALOL™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Nocturnal IOP at Week 4 | Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject 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). | Week 4: 10PM, 12AM, 2AM, 4AM, 6AM | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Diurnal IOP at Week 4 | Diurnal IOP (fluid pressure inside the eye) is the mean of the diurnal time points assessed (8 AM to 8 PM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject 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). | Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM | 
| Mean 24-hour IOP at Week 4 | 24-hour IOP (fluid pressure inside the eye) is the mean of all the time points assessed (8 AM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject 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). | Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM | 

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