NCT01978600

Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension

Prospective, Randomized, Single-Center Study to Evaluate 24-hour Intraocular Pressure Control With Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.

Detailed description

This study consisted of two phases, a Screening/Eligibility Phase and a Treatment Phase. Both phases required the patient to complete an overnight stay.

Conditions

• Open-Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension	Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.
DRUG	Timolol Maleate 0.5%	Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-11-07
• Last updated: 2015-04-13
• Results posted: 2015-04-13