Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension
- Conditions
- Glaucoma, Open-AngleOcular Hypertension
- Interventions
- Registration Number
- NCT02247804
- Lead Sponsor
- Allergan
- Brief Summary
This study will evaluate the efficacy and safety of bimatoprost SR in participants 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
- 594
-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 in either eye 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 Bimatoprost SR Study Eye: bimatoprost sustained release (SR) 15 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 Timolol Vehicle (placebo) Study Eye: bimatoprost sustained release (SR) 15 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 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 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 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 IOP in the Study Eye at Week 12 (Hours 0 and 2) Baseline (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 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 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 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 (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 (106)
Nature Coast Clinical Research
🇺🇸Crystal River, Florida, United States
Montebello Medical Eye Center Inc.
🇺🇸Montebello, California, United States
Glaucoma Institute of Beverly Hills
🇺🇸Los Angeles, California, United States
The Ohio State University Havener Eye Institute
🇺🇸Columbus, Ohio, United States
2000 North Village Avenue
🇺🇸Rockville Centre, New York, United States
Lifelong Vision Foundation
🇺🇸Chesterfield, Missouri, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
8 Medical Park Drive
🇺🇸Asheville, North Carolina, United States
Glaucoma Associates of Texas
🇺🇸Dallas, Texas, United States
Keystone Research, LTD
🇺🇸Austin, Texas, United States
Elo Oftalmologistas Associados
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Hamilton Glaucoma Center, Shiley Eye Center UCSD
🇺🇸La Jolla, California, United States
Ocular Immunology and Uveitis Foundation
🇺🇸Waltham, Massachusetts, United States
Minnesota Eye Constultants, P.A.
🇺🇸Bloomington, Minnesota, United States
Glaucoma Consultants of the Capital Region
🇺🇸Slingerlands, New York, United States
Melbourne Eye Specialists
🇦🇺Fitzroy, Australia
Vision Eye Institute Chatswood
🇦🇺Chatsworth, Australia
Escola Paulista de Medicina
🇧🇷Sao Paulo, Brazil
Uniwersytecki Szpital Kliniczny
🇵🇱Warszawa, Poland
Carmel Medical Center
🇮🇱Haifa, Israel
Retina Sp. z o.o
🇵🇱Warsaw, Poland
Public Clinical Hospital No. 1
🇵🇱Lublin, Poland
Klinika Okulistyki WIML
🇵🇱Warsaw, Poland
Hospital Universitario Rio Hortega
🇪🇸Valladolid, Spain
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Northern New Jersey Eye Institute P.A.
🇺🇸South Orange, New Jersey, United States
Drs Fine Hoffman & Sims, LLC
🇺🇸Eugene, Oregon, United States
Albemarle Clinical Trials, LLC
🇺🇸Elizabeth City, North Carolina, United States
Wills Eye Institute - Glaucoma Research Center
🇺🇸Philadelphia, Pennsylvania, United States
The Cataract, Glaucoma & Refractive Surgery Center
🇺🇸El Paso, Texas, United States
Lugene Eye Institute
🇺🇸Glendale, California, United States
Lakeside Vision Center
🇺🇸Irvine, California, United States
Atlantis Eye Care
🇺🇸Long Beach, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
Foothill Eye Institute
🇺🇸Pasadena, California, United States
Palm Beach Eye Center, INC
🇺🇸Atlantis, Florida, United States
Eye Associates of Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
Martel Eye Medical Group
🇺🇸Rancho Cordova, California, United States
Levenson Eye Associates
🇺🇸Jacksonville, Florida, United States
East Florida Eye Institute
🇺🇸Stuart, Florida, United States
Coastal Research Associates, LLC
🇺🇸Roswell, Georgia, United States
Chicago Eye Specialists
🇺🇸Chicago, Illinois, United States
Heart of America Eye Care PA
🇺🇸Shawnee Mission, Kansas, United States
Eye Doctors of Washington
🇺🇸Chevy Chase, Maryland, United States
MedRACS, LLC
🇺🇸Quincy, Massachusetts, United States
Eyecare Ophthalmology Associates, PC
🇺🇸Bethpage, New York, United States
Rochester Ophthalmological Group PC
🇺🇸Rochester, New York, United States
New York Eye and Ear Infirmary of Mount Sinai
🇺🇸New York, New York, United States
Associates in Ophthalmology
🇺🇸Pittsburgh, Pennsylvania, United States
VRF Eye Specialty Group
🇺🇸Memphis, Tennessee, United States
Preston Eye Clinic
🇦🇺Preston, Australia
Marsden Eye Specialists, Parramatta
🇦🇺Paramatta, Australia
Piedmont Eye Center
🇺🇸Lynchburg, Virginia, United States
Waverley Eye Clinic
🇦🇺Glen Waverley, Australia
University Hospitals Leuven
🇧🇪Leuven, Belgium
CHU Sart Tilman
🇧🇪Liege, Belgium
Universidade Federal de Goias
🇧🇷Goiania, Goias, Brazil
Nova Campinas Oftalmologia
🇧🇷Campinas, Sao Paulo, Brazil
Hospital das Clínicas - Faculdade de Medicina
🇧🇷Sao Paulo, Brazil
Glostrup Hospital
🇩🇰Glostrup, Denmark
Hospital Medicina dos Olhos
🇧🇷Osasco, Sao Paulo, Brazil
Hospital de Olhos MS
🇧🇷Rio Verde, Brazil
Markusovszky Korhaz
🇭🇺Szombathely, Hungary
Ganglion Medical Center
🇭🇺Pecs, Hungary
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Zala Megyei Kórház
🇭🇺Zalaegerszeg, Hungary
Rambam Medical Center
🇮🇱Haifa, Israel
Bnai Zion M.C.
🇮🇱Haifa, Israel
Pacific Eyecare & Laser Institute
🇵🇭Makati, Philippines
Makati Medical Center
🇵🇭Makati, Philippines
Asian Eye Institute
🇵🇭Makati, Philippines
Optimum Profesorskie Centrum Okulistyki
🇵🇱Gdansk, Poland
ZOZ OKO- TEST Poradnia Okulistyczna
🇵🇱Nowy Targ, Poland
Institut Clinic d'Oftalmologia
🇪🇸Barcelona, Spain
Uniwersyteck Szpital Kliniczny
🇵🇱Wroclaw, Poland
Hospital Universitario Reina Sofía
🇪🇸Cordoba, Spain
Institut Catala de la Retina
🇪🇸Barcelona, Spain
Hospital General de Catalunya
🇪🇸Barcelona, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital General
🇪🇸Valencia, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Buddhist Tzu Chi General Hospital (BTCGH)
🇨🇳Hualien, Taiwan
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
Arizona Glaucoma Specialists
🇺🇸Phoenix, Arizona, United States
Grutzmacher, Lewis and Sierra, Inc.
🇺🇸Sacramento, California, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Moyes Eye Center, PC
🇺🇸Kansas City, Missouri, United States
Nashville Vision Associates
🇺🇸Nashville, Tennessee, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
Focal Point Vision
🇺🇸San Antonio, Texas, United States
R and R Eye Research, LLC
🇺🇸San Antonio, Texas, United States
Pacific Eye Associates
🇺🇸San Francisco, California, United States
International Research Center
🇺🇸Tampa, Florida, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
University of Graz
🇦🇹Graz, Austria
University of Vienna
🇦🇹Vienna, Austria
Centro Oftalmológico Mácula Diagnóstico y Tratamiento
🇵🇪Lima, Peru
Prywatna Klinika Okulistyczna OFTALMIKA
🇵🇱Bydgoszcz, Poland
Diagnostic and Microsurgery Center of the Eye LENS
🇵🇱Olsztyn, Poland
Tulane Medical Center
🇺🇸New Orleans, Louisiana, United States
Carolinas Centers for Sight PC
🇺🇸Florence, South Carolina, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
The University of Hong Kong
🇭🇰Hong Kong, Hong Kong
Hong Kong Eye Hospital
🇭🇰Hong Kong, Hong Kong