NCT01937312

Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 282 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.

Detailed description

This study was divided into 2 sequential phases. The Screening/Eligibility Phase included one Screening Visit and two Eligibility Visits, during which subjects washed out of all other intraocular pressure (IOP)-lowering medications and dosed with TRAVATAN Z®, XALATAN®, or LUMIGAN®, 1 drop instilled in each eye once daily for 28 days. Subjects who met all inclusion/exclusion criteria were randomized at the second Eligibility Visit. The Treatment Phase consisted of two on-therapy visits (Week 2 and Week 6).

Conditions

• Ocular Hypertension
• Open Angle Glaucoma

Interventions

Type	Name	Description
DRUG	Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension
DRUG	Vehicle	Inactive ingredients used as a placebo comparator
DRUG	Prostaglandin analogue

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-09-09
• Last updated: 2015-07-28
• Results posted: 2015-06-08