Who is sponsoring NCT01937312?

NCT01937312 is sponsored by Alcon Research.

What condition does NCT01937312 study?

NCT01937312 studies Ocular Hypertension, Open Angle Glaucoma.

What drugs are being tested in NCT01937312?

Interventions: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension, Vehicle, Prostaglandin analogue.

What is the status of NCT01937312?

NCT01937312 is currently COMPLETED.

Last reviewed 2015-07-06 · How we verify

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

NCT01937312 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Alcon Research
Phase	Phase 4
Status	COMPLETED
Enrolment	282
Start date	2013-10
Completion	2014-05

Conditions

Ocular Hypertension
Open Angle Glaucoma

Interventions

Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension
Vehicle
Prostaglandin analogue

Primary outcomes

Mean Diurnal Intraocular Pressure (IOP) at Week 6 — Week 6
Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).