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

Completed · Phase 3

Conditions studied: Glaucoma, Ocular Hypertension

In brief

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.

Key facts

Study ID

NCT01177098

Run by

Allergan

People needed

561

Starts

2010-10-01

Expected to finish

2012-02-01

Last updated by the study team

2013-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has ocular hypertension or glaucoma in both eyes
• Requires IOP-lowering therapy in each eye

You may not qualify if…

• Active or recurrent eye disease that would interfere with interpretation of study data in either eye
• History of any eye surgery or laser in either eye within 6 months
• Required chronic use of other eye medications during the study
• Anticipated wearing of contact lenses during the study.
• Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days

Where it is running

• Study site — Artesia, California, United States
• Study site — Sydney, New South Wales, Australia
• Study site — Brno, Czechia
• Study site — Leipzig, Germany
• Study site — Budapest, Hungary
• Study site — Tel Aviv, Israel
• Study site — Saint Petersburg, Russia
• Study site — Valencia, Spain
• Study site — London, England, United Kingdom

Full record on ClinicalTrials.gov

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