Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension
- Conditions
- Ocular HypertensionOpen-Angle Glaucoma
- Interventions
- Registration Number
- NCT01157364
- Lead Sponsor
- Allergan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
- Diagnosis of open angle glaucoma or ocular hypertension
- Uncontrolled medical conditions
- Anticipated wearing of contact lenses during the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description bimatoprost 20 µg generation 2, bimatoprost 0.03% bimatoprost 20 µg generation 2 Single dose of bimatoprost ophthalmic 20 µg generation 2 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. bimatoprost 6 µg generation 2, bimatoprost 0.03% bimatoprost 6 µg generation 2 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). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. bimatoprost 15 µg generation 2, bimatoprost 0.03% bimatoprost 15 µg generation 2 Single dose of bimatoprost ophthalmic 15 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). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. bimatoprost 10 µg generation 2, bimatoprost 0.03% bimatoprost 10 µg generation 2 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). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. bimatoprost 15 µg generation 1, bimatoprost 0.03% bimatoprost 0.03% Single dose of bimatoprost ophthalmic 15 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. bimatoprost 10 µg generation 1, bimatoprost 0.03% bimatoprost 0.03% 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. bimatoprost 20 µg generation 2, bimatoprost 0.03% bimatoprost 0.03% Single dose of bimatoprost ophthalmic 20 µg generation 2 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. bimatoprost 10 µg generation 2, bimatoprost 0.03% bimatoprost 0.03% 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). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. bimatoprost 15 µg generation 2, bimatoprost 0.03% bimatoprost 0.03% Single dose of bimatoprost ophthalmic 15 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). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. bimatoprost 15 µg generation 1, bimatoprost 0.03% bimatoprost 15 µg generation 1 Single dose of bimatoprost ophthalmic 15 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. bimatoprost 10 µg generation 1, bimatoprost 0.03% bimatoprost 10 µg generation 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. bimatoprost 6 µg generation 2, bimatoprost 0.03% bimatoprost 0.03% 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). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
- Primary Outcome Measures
Name Time Method Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye Baseline, Month 24 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.
- Secondary Outcome Measures
Name Time Method Time to Rescue Treatment or Re-Treatment in the Study Eye 24 Months 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-Matched Intraocular Pressure (IOP) in the Study Eye Baseline to Month 6 IOP is a measurement of the fluid pressure inside the study eye.
Mean Diurnal IOP in the Study Eye Baseline, Month 6 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.
Trial Locations
- Locations (57)
Moyes Eye Center
🇺🇸Kansas City, Missouri, United States
Sall Research Medical Center
🇺🇸Artesia, California, United States
The Eye Associates of Manatee
🇺🇸Bradenton, Florida, United States
Glaucoma Consultants
🇺🇸Baltimore, Maryland, United States
Tufts Medical Center/New England Eye Center
🇺🇸Boston, Massachusetts, United States
Rochester Ophthalmological Group PC
🇺🇸Rochester, New York, United States
St. Lukes Medical Center-Quezon City
🇵🇭Metro Manila, Philippines
Shasta Eye Medical Group, Inc.
🇺🇸Redding, California, United States
Valles Oftalmologia Recerca, Hospital General de Catalunya,
🇪🇸Sant Cugat, Spain
Eye Associates
🇦🇺Sydney New South Wales, Australia
Clinical Eye Research of Boston/ Charles River Eye Associates
🇺🇸Winchester, Massachusetts, United States
Philadelphia Eye Associates
🇺🇸Philadelphia, Pennsylvania, United States
Northern New Jersey Eye Institute PA
🇺🇸South Orange, New Jersey, United States
Emory University, The Emory Eye Center
🇺🇸Atlanta, Georgia, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Ivey Eye Institute
🇨🇦London, Ontario, Canada
Kaplan Medical Center
🇮🇱Rohovot, Israel
Coastal Research Associates
🇺🇸Roswell, Georgia, United States
The Sam Rothberg Glaucoma Center,
🇮🇱Tel-Hashomer, Israel
UZ Leuven, Campus St. Rafael
🇧🇪Dienst Oogheelkunde, Belgium
Asian Eye Institute
🇵🇭Makati City, Philippines
Scott & Christie and Associates
🇺🇸Cranberry Township, Pennsylvania, United States
Glaucoma Associates of TX
🇺🇸Dallas, Texas, United States
Pacific Eye and Laser Institute (PELI)
🇵🇭Makati City, Philippines
Universidade Federal de São Paulo/Escola Paulista de Medicina/Hospital São Paulo Departamento de Oftalmologia
🇧🇷Sao Paulo, Brazil
Staedtisches Klinikum Department of Opthalmology
🇩🇪Karlsruhe, Germany
Singapore National Eye Center
🇸🇬Singapore, Singapore
Institut de l'œil des Laurentides
🇨🇦Boisbriand, Quebec, Canada
Doheny Eye Institute
🇺🇸Los Angeles, California, United States
Martel Eye Medical Group
🇺🇸Rancho Cordova, California, United States
Shiley Eye Center, Hamilton Glaucoma Center, University of California, San Diego
🇺🇸La Jolla, California, United States
Pacific Eye Surgeons
🇺🇸San Luis Obispo, California, United States
Specialty Eye Care
🇺🇸Parker, Colorado, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Glaucoma Associates of NY
🇺🇸New York, New York, United States
Galen Eye Centre
🇨🇦Kingston, Ontario, Canada
Eye Care Center
🇨🇦Halifax, Nova Scotia, Canada
Charlotte Eye Ear Nose & Throat Associates, PA
🇺🇸Charlotte, North Carolina, United States
Wolstan & Goldberg Eye Associates
🇺🇸Torrance, California, United States
Fundacion Oftalmologica Del Mediterraneo
🇪🇸Valencia, Spain
Clarity Eye Institute
🇨🇦Vaughan, Canada
ActivMed Practices & Research
🇺🇸Methuen, Massachusetts, United States
Cornerstone Eye Care
🇺🇸High Point, North Carolina, United States
Ophthalmic Consultants of Long Island
🇺🇸Lynbrook, New York, United States
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Spokane Eye Clinical Research
🇺🇸Spokane, Washington, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Melbourne Eye Specialists
🇦🇺Fitzroy, Australia
A.C. S. Crichton Prof. Corp
🇨🇦Calgary, Alberta, Canada
Anjema Eye Institute
🇨🇦Chatham, Ontario, Canada
Grutzmacher and Lewis, Inc.
🇺🇸Sacramento, California, United States
R and R Eye Research
🇺🇸San Antonio, Texas, United States
James D. Branch, MD
🇺🇸Winston-Salem, North Carolina, United States
Legacy Good Samaritan - Devers Eye Institute
🇺🇸Portland, Oregon, United States
Keystone Research LTD
🇺🇸Austin, Texas, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Focus Clinical Research
🇺🇸Salt Lake City, Utah, United States