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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
109
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Time frame: Baseline, Month 24
Time-Matched Intraocular Pressure (IOP) in the Study Eye
IOP is a measurement of the fluid pressure inside the study eye.
Time frame: Baseline to Month 6
Mean Diurnal IOP in the Study Eye
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0, 2, 4, 6, and 8 and averaged to determine the mean diurnal IOP.
Time frame: Baseline, Month 6
Time to Rescue Treatment or Re-Treatment in the Study Eye
Time to rescue treatment or the second treatment in the generation 2 groups is defined as the time between the first treatment and the second treatment in the study eye.
Time frame: 24 Months
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Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.
Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.
One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
Sall Research Medical Center
Artesia, California, United States
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
...and 47 more locations