Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension
NCT ID: NCT02247804
Last Updated: 2020-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
594 participants
INTERVENTIONAL
2014-12-15
2019-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bimatoprost SR 15 μg
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
Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
Active Comparator: Timolol 0.5%
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Sham: Applicator Without Needle
Sham administered on Day 1, Week 16, and Week 32.
Timolol Vehicle (placebo)
Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Bimatoprost SR 10 μg
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
Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
Active Comparator: Timolol 0.5%
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Sham: Applicator Without Needle
Sham administered on Day 1, Week 16, and Week 32.
Timolol Vehicle (placebo)
Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Timolol 0.5%
Study Eye and Non-Study Eye: sham administered 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.
Active Comparator: Timolol 0.5%
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Sham: Applicator Without Needle
Sham administered on Day 1, Week 16, and Week 32.
Interventions
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Bimatoprost SR
Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
Active Comparator: Timolol 0.5%
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Sham: Applicator Without Needle
Sham administered on Day 1, Week 16, and Week 32.
Timolol Vehicle (placebo)
Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Marina Bejanian
Role: STUDY_DIRECTOR
Allergan
Locations
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Arizona Glaucoma Specialists
Phoenix, Arizona, United States
Lugene Eye Institute
Glendale, California, United States
Lakeside Vision Center
Irvine, California, United States
Hamilton Glaucoma Center, Shiley Eye Center UCSD
La Jolla, California, United States
Atlantis Eye Care
Long Beach, California, United States
Glaucoma Institute of Beverly Hills
Los Angeles, California, United States
Montebello Medical Eye Center Inc.
Montebello, California, United States
Stanford University
Palo Alto, California, United States
Foothill Eye Institute
Pasadena, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Grutzmacher, Lewis and Sierra, Inc.
Sacramento, California, United States
Pacific Eye Associates
San Francisco, California, United States
Eye Associates of Colorado Springs
Colorado Springs, Colorado, United States
Palm Beach Eye Center, INC
Atlantis, Florida, United States
Nature Coast Clinical Research
Crystal River, Florida, United States
Levenson Eye Associates
Jacksonville, Florida, United States
East Florida Eye Institute
Stuart, Florida, United States
International Research Center
Tampa, Florida, United States
Coastal Research Associates, LLC
Roswell, Georgia, United States
Chicago Eye Specialists
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Heart of America Eye Care PA
Shawnee Mission, Kansas, United States
Tulane Medical Center
New Orleans, Louisiana, United States
Eye Doctors of Washington
Chevy Chase, Maryland, United States
MedRACS, LLC
Quincy, Massachusetts, United States
Ocular Immunology and Uveitis Foundation
Waltham, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Minnesota Eye Constultants, P.A.
Bloomington, Minnesota, United States
Lifelong Vision Foundation
Chesterfield, Missouri, United States
Moyes Eye Center, PC
Kansas City, Missouri, United States
Northern New Jersey Eye Institute P.A.
South Orange, New Jersey, United States
Eyecare Ophthalmology Associates, PC
Bethpage, New York, United States
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, United States
Rochester Ophthalmological Group PC
Rochester, New York, United States
2000 North Village Avenue
Rockville Centre, New York, United States
Glaucoma Consultants of the Capital Region
Slingerlands, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
8 Medical Park Drive
Asheville, North Carolina, United States
Albemarle Clinical Trials, LLC
Elizabeth City, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
The Ohio State University Havener Eye Institute
Columbus, Ohio, United States
Drs Fine Hoffman & Sims, LLC
Eugene, Oregon, United States
Wills Eye Institute - Glaucoma Research Center
Philadelphia, Pennsylvania, United States
Associates in Ophthalmology
Pittsburgh, Pennsylvania, United States
Carolinas Centers for Sight PC
Florence, South Carolina, United States
VRF Eye Specialty Group
Memphis, Tennessee, United States
Nashville Vision Associates
Nashville, Tennessee, United States
Keystone Research, LTD
Austin, Texas, United States
Glaucoma Associates of Texas
Dallas, Texas, United States
The Cataract, Glaucoma & Refractive Surgery Center
El Paso, Texas, 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
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Vision Eye Institute Chatswood
Chatsworth, , Australia
Melbourne Eye Specialists
Fitzroy, , Australia
Waverley Eye Clinic
Glen Waverley, , Australia
Marsden Eye Specialists, Parramatta
Paramatta, , Australia
Preston Eye Clinic
Preston, , Australia
University of Graz
Graz, , Austria
University of Vienna
Vienna, , Austria
University Hospitals Leuven
Leuven, , Belgium
CHU Sart Tilman
Liège, , Belgium
Universidade Federal de Goias
Goiânia, Goiás, Brazil
Elo Oftalmologistas Associados
Belo Horizonte, Minas Gerais, Brazil
Nova Campinas Oftalmologia
Campinas, São Paulo, Brazil
Hospital Medicina dos Olhos
Osasco, São Paulo, Brazil
Hospital de Olhos MS
Rio Verde, , Brazil
Escola Paulista de Medicina
São Paulo, , Brazil
Hospital das Clínicas - Faculdade de Medicina
São Paulo, , Brazil
Glostrup Hospital
Glostrup Municipality, , Denmark
Hong Kong Eye Hospital
Hong Kong, , Hong Kong
The University of Hong Kong
Hong Kong, , Hong Kong
Ganglion Medical Center
Pécs, , Hungary
Markusovszky Korhaz
Szombathely, , Hungary
Zala Megyei Kórház
Zalaegerszeg, , Hungary
Barzilai Medical Center
Ashkelon, , Israel
Bnai Zion M.C.
Haifa, , Israel
Rambam Medical Center
Haifa, , Israel
Carmel Medical Center
Haifa, , Israel
Centro Oftalmológico Mácula Diagnóstico y Tratamiento
Lima, , Peru
Asian Eye Institute
Makati, , Philippines
Pacific Eyecare & Laser Institute
Makati, , Philippines
Makati Medical Center
Makati, , Philippines
Prywatna Klinika Okulistyczna OFTALMIKA
Bydgoszcz, , Poland
Optimum Profesorskie Centrum Okulistyki
Gdansk, , Poland
Public Clinical Hospital No. 1
Lublin, , Poland
ZOZ OKO- TEST Poradnia Okulistyczna
Nowy Targ, , Poland
Diagnostic and Microsurgery Center of the Eye LENS
Olsztyn, , Poland
Retina Sp. z o.o
Warsaw, , Poland
Klinika Okulistyki WIML
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny
Warsaw, , Poland
Uniwersyteck Szpital Kliniczny
Wroclaw, , Poland
Institut Clinic d'Oftalmologia
Barcelona, , Spain
Institut Catala de la Retina
Barcelona, , Spain
Hospital General de Catalunya
Barcelona, , Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital General
Valencia, , Spain
Hospital Universitario Rio Hortega
Valladolid, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Buddhist Tzu Chi General Hospital (BTCGH)
Hualien City, Hualien, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Countries
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References
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Weinreb RN, Bacharach J, Brubaker JW, Medeiros FA, Bejanian M, Bernstein P, Robinson MR. Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies. J Ocul Pharmacol Ther. 2023 Jan-Feb;39(1):55-62. doi: 10.1089/jop.2022.0137. Epub 2022 Nov 15.
Medeiros FA, Sheybani A, Shah MM, Rivas M, Bai Z, Werts E, Ahmed IIK, Craven ER. Single Administration of Intracameral Bimatoprost Implant 10 microg in Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmol Ther. 2022 Aug;11(4):1517-1537. doi: 10.1007/s40123-022-00527-6. Epub 2022 May 28.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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More Information
Other Identifiers
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2014-003037-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
192024-091
Identifier Type: -
Identifier Source: org_study_id
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