NCT02419508

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Open-Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension
DRUG	Brinz/brim vehicle	Inactive ingredients used as a placebo for masking purposes
DRUG	Prostaglandin analogue

Timeline

• Start date: 2015-08-07
• Primary completion: 2018-02-27
• Completion: 2018-02-27
• First posted: 2015-04-17
• Last updated: 2018-11-15
• Results posted: 2018-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study