Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension

Completed · Phase 1/Phase 2

Conditions studied: Open-Angle Glaucoma, Ocular Hypertension

In brief

This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.

Key facts

Study ID

NCT01157364

Run by

Allergan

People needed

109

Starts

2010-09-23

Expected to finish

2016-08-09

Last updated by the study team

2020-03-30

Who can join

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

You may qualify if…

• Diagnosis of open angle glaucoma or ocular hypertension

You may not qualify if…

• Uncontrolled medical conditions
• Anticipated wearing of contact lenses during the study

Where it is running

• Shiley Eye Center, Hamilton Glaucoma Center, University of California, San Diego — La Jolla, California, United States
• Doheny Eye Institute — Los Angeles, California, United States
• Martel Eye Medical Group — Rancho Cordova, California, United States
• Shasta Eye Medical Group, Inc. — Redding, California, United States
• Grutzmacher and Lewis, Inc. — Sacramento, California, United States
• Pacific Eye Surgeons — San Luis Obispo, California, United States
• Wolstan & Goldberg Eye Associates — Torrance, California, United States
• Specialty Eye Care — Parker, Colorado, United States
• The Eye Associates of Manatee — Bradenton, Florida, United States
• Emory University, The Emory Eye Center — Atlanta, Georgia, United States
• Coastal Research Associates — Roswell, Georgia, United States
• Springfield Clinic — Springfield, Illinois, United States
• Glaucoma Consultants — Baltimore, Maryland, United States
• Tufts Medical Center/New England Eye Center — Boston, Massachusetts, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• ActivMed Practices & Research — Methuen, Massachusetts, United States
• Clinical Eye Research of Boston/ Charles River Eye Associates — Winchester, Massachusetts, United States
• Moyes Eye Center — Kansas City, Missouri, United States
• Northern New Jersey Eye Institute PA — South Orange, New Jersey, United States
• Ophthalmic Consultants of Long Island — Lynbrook, New York, United States
• Glaucoma Associates of NY — New York, New York, United States
• Rochester Ophthalmological Group PC — Rochester, New York, United States
• Charlotte Eye Ear Nose & Throat Associates, PA — Charlotte, North Carolina, United States
• Cornerstone Eye Care — High Point, North Carolina, United States
• Sall Research Medical Center — Artesia, California, United States

Full record on ClinicalTrials.gov

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