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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-07

Study Completion Date

2018-02-27

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.

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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.

Conditions

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Open-Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SIMBRINZA + PGA

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

Group Type EXPERIMENTAL

Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension

Intervention Type DRUG

Prostaglandin analogue

Intervention Type DRUG

Vehicle + PGA

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

Group Type OTHER

Brinz/brim vehicle

Intervention Type DRUG

Inactive ingredients used as a placebo for masking purposes

Prostaglandin analogue

Intervention Type DRUG

Interventions

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Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension

Intervention Type DRUG

Brinz/brim vehicle

Inactive ingredients used as a placebo for masking purposes

Intervention Type DRUG

Prostaglandin analogue

Intervention Type DRUG

Other Intervention Names

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SIMBRINZA® suspension TRAVATAN® PQ (Travoprost ophthalmic solution with PQ, 0.004%) LUMIGAN® (Bimatoprost ophthalmic solution, 0.01%) XALATAN® (Latanoprost ophthalmic solution, 0.005%)

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;

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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No