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

Condition(s) targeted: Glaucoma; Ocular Hypertension

Intervention: bimatoprost /timolol formulation A fixed combination ophthalmic solution (Drug); bimatoprost/timolol fixed combination ophthalmic solution (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12

Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2

Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6

Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12

Secondary outcome:

Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12

Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient has ocular hypertension or glaucoma in both eyes

- Requires IOP-lowering therapy in each eye

Exclusion Criteria:

- 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

Brno, Czech Republic

Leipzig, Germany

Budapest, Hungary

Tel Aviv, Israel

Saint-Petersburg, Russian Federation

Valencia, Spain

Artesia, California, United States

London, England, United Kingdom

Sydney, New South Wales, Australia

Starting date: October 2010
Last updated: March 22, 2013