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

Phase 4

Completed

Conditions: Open-Angle Glaucoma
Ocular Hypertension

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

Registration Number: NCT02419508

Lead Sponsor: Alcon Research

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 290

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SIMBRINZA + PGA	Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension	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
SIMBRINZA + PGA	Prostaglandin analogue	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
Vehicle + PGA	Brinz/brim vehicle	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
Vehicle + PGA	Prostaglandin analogue	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

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Mean Diurnal IOP at Week 6	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.
Mean Percentage Change From Baseline in Diurnal IOP at Week 6	Baseline, 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.
Mean Change From Baseline in IOP at 11:00 at Week 6	Baseline, 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.
Mean Percentage Change From Baseline in IOP at 11:00 at Week 6	Baseline, 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.
Mean Change From Baseline in IOP at 09:00 at Week 6	Baseline, 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.
Mean Percentage Change From Baseline at 09:00 at Week 6	Baseline, 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.