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

Alcon

Status and phase: Completed; Phase 4

Conditions: Open-Angle Glaucoma; Ocular Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02419508

REec-2015-1723 (Registry Identifier)

GLH694-P001

2015-000736-15 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 290 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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290 participants in 2 patient groups

SIMBRINZA + PGA

Experimental group

Description:

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

Treatment:

Drug: Prostaglandin analogue

Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension

Vehicle + PGA

Other group

Description:

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

Treatment:

Drug: Prostaglandin analogue

Drug: Brinz/brim vehicle