Effect of SIMBRINZA® Suspension as an Added Therapy to TRAVATAN Z®

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy (TRAVATAN Z®).

Detailed Description
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This study was divided into 2 sequential phases. The Screening/Eligibility Phase included one Screening Visit and two Eligibility Visits, during which subjects washed out of all other intraocular pressure (IOP)-lowering medications and dosed with TRAVATAN Z®, 1 drop instilled in each eye once daily for 28 days. Subjects who met all inclusion/exclusion criteria were randomized at the second Eligibility Visit. The Treatment Phase consisted of two on-therapy visits (Week 2 and Week 6).

Official Title
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Additive Effect of Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination As Adjunctive Therapy to Travoprost

Conditions
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Ocular Hypertension, Open Angle Glaucoma

Intervention / Treatment
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* Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension
* Drug: Vehicle
* Drug: Travoprost 0.004% ophthalmic solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of open angle glaucoma or ocular hypertension; Mean IOP measurements in at least 1 eye (study eye) of ≥ 21 mmHg and <32 mmHg at 8 AM while on travoprost monotherapy at 2 consecutive visits (Eligibility 1 and Eligibility 2); Able to understand and sign Informed Consent form; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Women of childbearing potential who are pregnant, breastfeeding, or do not agree to use an adequate birth control method throughout the study; Any form of glaucoma other than open angle glaucoma or ocular hypertension; Severe central visual field loss; Chronic, recurrent, or severe inflammatory eye disease; Ocular trauma within the past 6 months; Ocular infection or ocular inflammation within the past 3 months; Best-corrected visual acuity score worse than approximately 20/80 Snellen; Eye surgery within the past 6 months; Any condition, including severe illness, which would make the subject unsuitable for the study in the opinion of the Investigator; Use of any additional topical or systemic ocular hypertensive medication during the study; Patients who, in the opinion of the Investigator, cannot discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to Eligibility 1 Visit; 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIMBRINZA<br>Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks | Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension<br> <br> * Other names: SIMBRINZA®;Drug: Travoprost 0.004% ophthalmic solution<br> <br> * Other names: TRAVATAN Z®;|
| Placebo Comparator: Vehicle<br>Inactive ingredients, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks | Drug: Vehicle<br>* Inactive ingredients used as a placebo comparator<br>Drug: Travoprost 0.004% ophthalmic solution<br> <br> * Other names: TRAVATAN Z®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Diurnal Intraocular Pressure (IOP) at Week 6 | Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Diurnal IOP Change From Baseline to Week 6 | Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. | Baseline, Week 6 | 
| Mean Diurnal IOP Percentage Change From Baseline to Week 6 | Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. | Baseline, Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, prostaglandin analogue, brinzolamide, brimonidine