NCT01177098

Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 561 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.

Conditions

• Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	bimatoprost /timolol formulation A fixed combination ophthalmic solution	One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
DRUG	bimatoprost/timolol fixed combination ophthalmic solution	One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-08-06
• Last updated: 2013-03-29
• Results posted: 2013-03-12

Locations

9 sites across 9 countries: United States, Australia, Czechia, Germany, Hungary, Israel, Russia, Spain, United Kingdom