NCT00961649

Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination

Safety and IOP-Lowering Efficacy of Brinzolamide/Brimonidine Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma and/or Ocular Hypertension

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to compare the safety and intraocular pressure (IOP)-lowering efficacy of a new fixed combination of brinzolamide/brimonidine (Brinz/Brim) to: * its individual components (Brinz and Brim), and * the concomitant administration of Brinz and Brim (Brinz+Brim).

Detailed description

This study consisted of 5 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and the treatment phase, which included 2 on-therapy visits conducted at Week 2 and Week 6 (or early exit). A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 4 study drug groups for 6 weeks. Study drug instillation began the morning after the second eligibility visit. The study was terminated by the sponsor out of caution due to microgel formation in the Brinz/Brim formulation. 13 remaining active subjects were discontinued. Further analysis revealed that neither the drop size nor the concentration of the active ingredients was affected.

Conditions

• Open-Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
DRUG	Brinzolamide ophthalmic suspension, 1%
DRUG	Brimonidine tartrate ophthalmic solution, 0.2%
OTHER	Vehicle	Inactive ingredients used as placebo

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2009-08-19
• Last updated: 2013-07-04
• Results posted: 2013-07-04