SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (BID)) when added to a prostaglandin analogue (PGA) in subjects with open-angle glaucoma or ocular hypertension.

Detailed Description
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This study consisted of 2 sequential phases: Screening/Eligibility Phase, followed by a Masked Treatment Phase (Phase II). Subjects were assigned into one of 3 PGA therapy groups for the duration of the study, based upon commercial availability.

Official Title
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Additive Effect of Twice Daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue

Conditions
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Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension
* Drug: Brinz/brim vehicle
* Drug: Prostaglandin analogue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of either open-angle glaucoma or ocular hypertension; Must sign an informed consent form; Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye[s]) ≥ 19 and < 32 mmHg at 09:00. Willing and able to attend all study visits; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study; Any form of glaucoma other than open-angle glaucoma or ocular hypertension; Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol; Any other conditions including severe illness which would 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIMBRINZA + PGA<br>Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days | Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension<br> <br> * Other names: SIMBRINZA® suspension;Drug: Prostaglandin analogue<br> <br> * Other names: XALATAN® (Latanoprost ophthalmic solution, 0.005%);|
| Other: Vehicle + PGA<br>Brinz/brim vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days | Drug: Brinz/brim vehicle<br>* Inactive ingredients used as a placebo for masking purposes<br>Drug: Prostaglandin analogue<br> <br> * Other names: XALATAN® (Latanoprost ophthalmic solution, 0.005%);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6 | IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis. | Baseline, Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Diurnal IOP at Week 6 | IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. | Week 6 | 
| Mean Percentage Change From Baseline in Diurnal IOP at Week 6 | IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis. | Baseline, Week 6 | 
| Mean Change From Baseline in IOP at 11:00 at Week 6 | IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis. | Baseline, Week 6 | 
| Mean Percentage Change From Baseline in IOP at 11:00 at Week 6 | IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis. | Baseline, Week 6 | 
| Mean Change From Baseline in IOP at 09:00 at Week 6 | IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 09:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis. | Baseline, Week 6 | 
| Mean Percentage Change From Baseline at 09:00 at Week 6 | IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 9:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits.A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis. | Baseline, Week 6 |