Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension
- Conditions
- Ocular HypertensionGlaucoma, Open-Angle
- Interventions
- Registration Number
- NCT02250651
- Lead Sponsor
- Allergan
- Brief Summary
This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 528
- Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.
- Previous enrollment in another Allergan Bimatoprost SR Study
- Eye surgery (including cataract surgery) and/or any eye laser surgery within the past 6 months in the study eye
- Anticipated need for laser eye surgery within the first 52 weeks of the study duration
- History of glaucoma surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bimatoprost SR 15 μg Timolol Vehicle (placebo) Study Eye: bimatoprost sustained-release (SR) 15 micrograms (μg) administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. Bimatoprost SR 10 μg Bimatoprost SR Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. Bimatoprost SR 15 μg Bimatoprost SR Study Eye: bimatoprost sustained-release (SR) 15 micrograms (μg) administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. Bimatoprost SR 10 μg Timolol Vehicle (placebo) Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
- Primary Outcome Measures
Name Time Method IOP in the Study Eye at Week 2 (Hour 0) Week 2 (Hour 0) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2) Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
IOP in the Study Eye at Week 6 (Hour 2) Week 6 (Hour 2) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
IOP in the Study Eye at Week 6 (Hour 0) Week 6 (Hour 0) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
IOP in the Study Eye at Week 2 (Hour 2) Week 2 (Hour 2) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
IOP in the Study Eye at Week 12 (Hour 0) Week 12 (Hour 0) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
IOP in the Study Eye at Week 12 (Hour 2) Week 12 (Hour 2) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
- Secondary Outcome Measures
Name Time Method Change From Baseline in IOP in the Study Eye Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Trial Locations
- Locations (113)
Sunnybrook Research Institute
🇨🇦Toronto, Ontario, Canada
Mark B. Kislinger, MD, Inc.
🇺🇸Glendora, California, United States
Southern California Eye Physicians and Surgeons
🇺🇸Los Alamitos, California, United States
Inland Eye Specialists
🇺🇸Hemet, California, United States
Eye Research Foundation
🇺🇸Newport Beach, California, United States
Eye Associates of Fort Myers
🇺🇸Fort Myers, Florida, United States
Eye Clinic at Shands Medical Plaza
🇺🇸Gainesville, Florida, United States
Kentuckiana Institute for Eye Research at Bennett & Bloom Eye Centers White House Office Complex
🇺🇸Louisville, Kentucky, United States
Clinical Eye Research of Boston, Co.
🇺🇸Winchester, Massachusetts, United States
Tekwani Vision Center
🇺🇸Saint Louis, Missouri, United States
Rutgers-New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Charlotte Eye Ear Nose & Throat Associates, PA
🇺🇸Charlotte, North Carolina, United States
Wenatchee valley Hospital & Clinics, Clinical research department
🇺🇸Wenatchee, Washington, United States
Organización Médica de Investigación
🇦🇷Ciudad Autónoma de BuenosAires, Argentina
Trimed Eye Center
🇨🇦Barrie, Ontario, Canada
Fundacion Oftalmologica de Santander Foscal
🇨🇴Floridablanca, Santander, Colombia
Ain Shams University Hospital
🇪🇬Cairo, Egypt
Al Kasr Al Ainy Cairo University Hospital
🇪🇬Cairo, Egypt
Università degli Studi G. D'Annunzio Chieti-Pescara
🇮🇹Chieti, Abruzzo, Italy
Princess Alexandra Eye Pavilion
🇬🇧Edinburgh, United Kingdom
St Paul's Eye Unit Royal Liverpool&Broadgreen, NHS Trust
🇬🇧Liverpool, United Kingdom
Alkek Eye Center
🇺🇸Houston, Texas, United States
University of California (UCSF) Department of Ophthalmology
🇺🇸San Francisco, California, United States
Bergstrom Eye and Laser Clinic
🇺🇸Fargo, North Dakota, United States
Vold Vision
🇺🇸Fayetteville, Arkansas, United States
Clinique d' ophtalmologie Dr Saurel
🇨🇦Drummondville, Quebec, Canada
Centro Medico Oftalmologia Global
🇦🇷Rosario, Santa Fe, Argentina
Centro Médico Grupo Laser Visión
🇦🇷Rosario, Santa Fe, Argentina
Hospital Universitario Austral
🇦🇷Pilar, Buenos Aires, Argentina
Specialty Retinal Center
🇺🇸Coral Springs, Florida, United States
Center for Sight
🇺🇸Sarasota, Florida, United States
Legacy Good Samaritan Hospital - Devers Eye Institute
🇺🇸Portland, Oregon, United States
Eye Center South
🇺🇸Dothan, Alabama, United States
Shasta Eye Medical Group, Inc.
🇺🇸Redding, California, United States
Shepard Eye Center
🇺🇸Santa Maria, California, United States
Wolstan & Goldberg Eye Associates
🇺🇸Torrance, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Insight Vision Group
🇺🇸Parker, Colorado, United States
Danbury Eye Physicians and Surgeons PC
🇺🇸Danbury, Connecticut, United States
Argus Research at Cape Coral Eye Center
🇺🇸Cape Coral, Florida, United States
Bruce A Segal, M.D.
🇺🇸Delray Beach, Florida, United States
Bascom Palmer Eye Institute, University of Miami
🇺🇸Palm Beach Gardens, Florida, United States
MedEye Associates
🇺🇸South Miami, Florida, United States
Johns Hopkins School of Medicine, Wilmer Eye Institute
🇺🇸Baltimore, Maryland, United States
Eye Associates of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Alterman, Modi & Wolter
🇺🇸Poughkeepsie, New York, United States
South Shore Eye Care, LLP
🇺🇸Wantagh, New York, United States
Scheie Eye Institute, Department of Ophthalmology, University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Vistar Eye Center
🇺🇸Roanoke, Virginia, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
DCT-Shah Research, LLC dba Discovery ClinicalTrials
🇺🇸Mission, Texas, United States
Key Whitman Eye Center
🇺🇸Plano, Texas, United States
The Eye Centers of Racine and Kenosha
🇺🇸Racine, Wisconsin, United States
Instituto Oftalmologico de Buenos Aires Oftalmos
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Clinica Privada de Ojos
🇦🇷Mar del Plata, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires - Hospital
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Oftar Centro Privado de Oftalmologia
🇦🇷Mendoza, Argentina
Nova Scotia Health Authority, Department of Ophthalmology & Visual Sciences
🇨🇦Halifax, Nova Scotia, Canada
ACS Crichton Prof. Corp
🇨🇦Calgary, Alberta, Canada
Uptown Eye Specialists
🇨🇦Concord, Ontario, Canada
Galen Eye Centre
🇨🇦Kingston, Ontario, Canada
Ophthalmic Consultant Centres Inc
🇨🇦Mississauga, Ontario, Canada
Institut De L'Oeil Des Laurentides
🇨🇦Boisbriand, Quebec, Canada
Bellevue Clinic
🇨🇦Montreal, Quebec, Canada
Clinica de Oftalmologia Sandiego S.A.
🇨🇴Medellin, Antioquia, Colombia
GOGiunta Ophtalmologie
🇨🇦Sherbrooke, Quebec, Canada
Fundación Oftalmologica Nacional Fundonal
🇨🇴Bogota, Distrito Capital De Bogota, Colombia
Ocni klinika
🇨🇿Brno, Jihlavska, Czechia
Ocni klinika Pardubice
🇨🇿Prague, Czechia
Instituto de Investigaciones, Centro Médico Imbanaco de Cali S.A.
🇨🇴Cali, Colombia
Nemocnicni Lekarna
🇨🇿Hradec Kralove, Sokolska, Czechia
Universitätsklinik Magdeburg
🇩🇪Magdeburg, Sachsen-Anhalt, Germany
Menoufia University Hospital
🇪🇬Shibīn al-Kawm, Cairo, Egypt
Augen Zentrum Nordwest
🇩🇪Ahaus, Nordrhein-Westfalen, Germany
Klinikum der Universität Regensburg
🇩🇪Regensburg, Bayern, Germany
Augenärzte am St. Franziskus-Hospital
🇩🇪Munster, Nordrhein-Westfalen, Germany
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
🇮🇹Catania, Sicilia, Italy
Azienda Ospedaliera-Polo Universitario San Paolo
🇮🇹Milano, Lombardia, Italy
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Oculistica Universitaria Università Degli Studi di Pisa - Ospedale di Cisanello Pisa
🇮🇹Pisa, Toscana, Italy
Ospedale Santa Maria Della Misericordia
🇮🇹Perugia, Italy
Unità Operativa di Oculistica Ospedale San Raffaele S.r.l.
🇮🇹Milano, Italy
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Kuala Lumpur Jalan Pahang, Department of Opthalmology
🇲🇾Cheras, Kuala Lumpur, Malaysia
Changi General Hospital
🇸🇬Singapore, Singapore
Capital Eye Specialists
🇳🇿Wellington, New Zealand
Horizon Eye Care Centre
🇿🇦Bloemfontein, Free State, South Africa
National University Hospital
🇸🇬Singapore, Singapore
Singapore National Eye Centre
🇸🇬Singapore, Singapore
Pretoria Eye Institute
🇿🇦Arcadia, Pretoria, South Africa
Eskisehir Osmangazi Universitesi Goz Hastaliklari Anabilim Dali
🇹🇷Meselik, Eskisehir, Turkey
Marmara Universitesi Pendik Egitim Arastirma Hastanesi Goz Hastaliklari
🇹🇷Pendik, Istanbul, Turkey
Celal Bayar Universitesi Tip Fakultesi Goz Hastaliklari Anabilim Dali
🇹🇷Manisa, Turkey
In Patient Pharmacy, Ground Floor, Lambeth Wing St Thomas' Hospital
🇬🇧London, United Kingdom
ICORG
🇬🇧London, United Kingdom
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
Queen Alexandra Hospital
🇬🇧Cosham, United Kingdom
James Paget University Hosp NHS Foundation Trust
🇬🇧Great Yarmouth, United Kingdom
Aintree University Hospital NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
Peterborough City Hospital Research and Development Department
🇬🇧Peterborough, United Kingdom
James D. Branch, MD
🇺🇸Winston-Salem, North Carolina, United States
North Bay Eye Associates, Inc.
🇺🇸Petaluma, California, United States
Pacific Eye Surgeons
🇺🇸San Luis Obispo, California, United States
East West Eye Institute
🇺🇸Torrance, California, United States
Emory University Eye Center
🇺🇸Atlanta, Georgia, United States
Lehigh Valley Eye Center, P.C.
🇺🇸Allentown, Pennsylvania, United States
Specialty Eyecare Centre
🇺🇸Bellevue, Washington, United States
Virdi Eye Clinic
🇺🇸Rock Island, Illinois, United States
Scott & Christie and Associates, PC
🇺🇸Cranberry Township, Pennsylvania, United States
Klinisches Studienzentrum
🇩🇪Mainz, Germany
Arizona Eye Center
🇺🇸Chandler, Arizona, United States