Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension
The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension
2 other identifiers
interventional
528
15 countries
113
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2014
Longer than P75 for phase_3
113 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2014
CompletedFirst Posted
Study publicly available on registry
September 26, 2014
CompletedStudy Start
First participant enrolled
December 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2020
CompletedResults Posted
Study results publicly available
July 28, 2021
CompletedJuly 28, 2021
June 1, 2021
3.9 years
September 23, 2014
April 29, 2021
July 6, 2021
Conditions
Outcome Measures
Primary Outcomes (7)
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye 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.
Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)
IOP in the Study Eye at 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.
Week 2 (Hour 0)
IOP in the Study Eye at 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.
Week 2 (Hour 2)
IOP in the Study Eye at 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.
Week 6 (Hour 0)
IOP in the Study Eye at 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.
Week 6 (Hour 2)
IOP in the Study Eye at 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.
Week 12 (Hour 0)
IOP in the Study Eye at 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.
Week 12 (Hour 2)
Secondary Outcomes (1)
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)
Study Arms (3)
Bimatoprost SR 15 μg
EXPERIMENTALStudy 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
EXPERIMENTALStudy 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.
Timolol 0.5%: Comparator
ACTIVE COMPARATORBoth Eyes: 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.
Interventions
Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
Sham administered on Day 1, Week 16, and Week 32.
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Eligibility Criteria
You may qualify if:
- \- Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (113)
Eye Center South
Dothan, Alabama, 36301, United States
Arizona Eye Center
Chandler, Arizona, 85224, United States
Vold Vision
Fayetteville, Arkansas, 72704, United States
Mark B. Kislinger, MD, Inc.
Glendora, California, 91741, United States
Inland Eye Specialists
Hemet, California, 92545, United States
Southern California Eye Physicians and Surgeons
Los Alamitos, California, 90720, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
North Bay Eye Associates, Inc.
Petaluma, California, 94954, United States
Shasta Eye Medical Group, Inc.
Redding, California, 96002, United States
University of California (UCSF) Department of Ophthalmology
San Francisco, California, 94143, United States
Pacific Eye Surgeons
San Luis Obispo, California, 93401, United States
Shepard Eye Center
Santa Maria, California, 93454, United States
East West Eye Institute
Torrance, California, 90505, United States
Wolstan & Goldberg Eye Associates
Torrance, California, 90505, United States
University of Colorado
Aurora, Colorado, 80045, United States
Insight Vision Group
Parker, Colorado, 80134, United States
Danbury Eye Physicians and Surgeons PC
Danbury, Connecticut, 06810, United States
Argus Research at Cape Coral Eye Center
Cape Coral, Florida, 33904, United States
Specialty Retinal Center
Coral Springs, Florida, 33067, United States
Bruce A Segal, M.D.
Delray Beach, Florida, 33484, United States
Eye Associates of Fort Myers
Fort Myers, Florida, 33901, United States
Eye Clinic at Shands Medical Plaza
Gainesville, Florida, 32608, United States
Bascom Palmer Eye Institute, University of Miami
Palm Beach Gardens, Florida, 33418, United States
Center for Sight
Sarasota, Florida, 34239, United States
MedEye Associates
South Miami, Florida, 33143-3693, United States
Emory University Eye Center
Atlanta, Georgia, 30322, United States
Virdi Eye Clinic
Rock Island, Illinois, 61201, United States
Kentuckiana Institute for Eye Research at Bennett & Bloom Eye Centers White House Office Complex
Louisville, Kentucky, 40215, United States
Johns Hopkins School of Medicine, Wilmer Eye Institute
Baltimore, Maryland, 21287, United States
Clinical Eye Research of Boston, Co.
Winchester, Massachusetts, 01890, United States
Tekwani Vision Center
St Louis, Missouri, 63128, United States
Rutgers-New Jersey Medical School
Newark, New Jersey, 07103, United States
Eye Associates of New Mexico
Albuquerque, New Mexico, 87109, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Alterman, Modi & Wolter
Poughkeepsie, New York, 12603, United States
South Shore Eye Care, LLP
Wantagh, New York, 11793, United States
Charlotte Eye Ear Nose & Throat Associates, PA
Charlotte, North Carolina, 28210, United States
James D. Branch, MD
Winston-Salem, North Carolina, 27101, United States
Bergstrom Eye and Laser Clinic
Fargo, North Dakota, 58103, United States
Legacy Good Samaritan Hospital - Devers Eye Institute
Portland, Oregon, 97210, United States
Lehigh Valley Eye Center, P.C.
Allentown, Pennsylvania, 18104, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16006, United States
Scheie Eye Institute, Department of Ophthalmology, University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Alkek Eye Center
Houston, Texas, 77030, United States
DCT-Shah Research, LLC dba Discovery ClinicalTrials
Mission, Texas, 78572, United States
Key Whitman Eye Center
Plano, Texas, 75093, United States
Vistar Eye Center
Roanoke, Virginia, 24016, United States
Specialty Eyecare Centre
Bellevue, Washington, 98004, United States
Wenatchee valley Hospital & Clinics, Clinical research department
Wenatchee, Washington, 98801, United States
The Eye Centers of Racine and Kenosha
Racine, Wisconsin, 53405, United States
Instituto Oftalmologico de Buenos Aires Oftalmos
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1120AAN, Argentina
Hospital Italiano de Buenos Aires - Hospital
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1181ACH, Argentina
Clinica Privada de Ojos
Mar del Plata, Buenos Aires, 7600, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, B1629ODT, Argentina
Centro Medico Oftalmologia Global
Rosario, Santa Fe Province, 2000, Argentina
Centro Médico Grupo Laser Visión
Rosario, Santa Fe Province, S2000AZH, Argentina
Organización Médica de Investigación
Ciudad Autónoma de BuenosAires, C1015ABO, Argentina
Oftar Centro Privado de Oftalmologia
Mendoza, 5500, Argentina
ACS Crichton Prof. Corp
Calgary, Alberta, T3E-7M8, Canada
Nova Scotia Health Authority, Department of Ophthalmology & Visual Sciences
Halifax, Nova Scotia, B3H 2Y9, Canada
Trimed Eye Center
Barrie, Ontario, L4M455, Canada
Uptown Eye Specialists
Concord, Ontario, L4K225, Canada
Galen Eye Centre
Kingston, Ontario, K7K 6Z6, Canada
Ophthalmic Consultant Centres Inc
Mississauga, Ontario, L4W1W9, Canada
Sunnybrook Research Institute
Toronto, Ontario, M4N3M5, Canada
Institut De L'Oeil Des Laurentides
Boisbriand, Quebec, J7J 2BJ, Canada
Clinique d' ophtalmologie Dr Saurel
Drummondville, Quebec, J2C 2C4, Canada
Bellevue Clinic
Montreal, Quebec, H1V 1GS, Canada
GOGiunta Ophtalmologie
Sherbrooke, Quebec, J1G 2V4, Canada
Clinica de Oftalmologia Sandiego S.A.
Medellín, Antioquia, 0000, Colombia
Fundación Oftalmologica Nacional Fundonal
Bogotá, Bogota D.C., 110231, Colombia
Fundacion Oftalmologica de Santander Foscal
Floridablanca, Santander Department, 680004, Colombia
Instituto de Investigaciones, Centro Médico Imbanaco de Cali S.A.
Cali, 760001, Colombia
Ocni klinika
Brno, Jihlavska, 62500, Czechia
Nemocnicni Lekarna
Hradec Králové, Sokolska, 50005, Czechia
Ocni klinika Pardubice
Prague, 53002, Czechia
Menoufia University Hospital
Shibīn al-Kawm, Cairo Governorate, 32111, Egypt
Al Kasr Al Ainy Cairo University Hospital
Cairo, 11562, Egypt
Ain Shams University Hospital
Cairo, 11566, Egypt
Klinikum der Universität Regensburg
Regensburg, Bavaria, 93053, Germany
Augen Zentrum Nordwest
Ahaus, North Rhine-Westphalia, 48683, Germany
Augenärzte am St. Franziskus-Hospital
Münster, North Rhine-Westphalia, 48145, Germany
Universitätsklinik Magdeburg
Magdeburg, Saxony-Anhalt, 39120, Germany
Klinisches Studienzentrum
Mainz, 55131, Germany
Università degli Studi G. D'Annunzio Chieti-Pescara
Chieti, Abruzzo, 66013, Italy
Azienda Ospedaliera-Polo Universitario San Paolo
Milan, Lombardy, 20142, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, Sicily, 95123, Italy
Oculistica Universitaria Università Degli Studi di Pisa - Ospedale di Cisanello Pisa
Pisa, Tuscany, 56124, Italy
Unità Operativa di Oculistica Ospedale San Raffaele S.r.l.
Milan, 20132, Italy
Ospedale Santa Maria Della Misericordia
Perugia, 06156, Italy
Hospital Kuala Lumpur Jalan Pahang, Department of Opthalmology
Cheras, Kuala Lumpur, 50586, Malaysia
Capital Eye Specialists
Wellington, 06011, New Zealand
National University Hospital
Singapore, 119074, Singapore
Singapore National Eye Centre
Singapore, 168751, Singapore
Changi General Hospital
Singapore, 529889, Singapore
Horizon Eye Care Centre
Bloemfontein, Free State, 9301, South Africa
Pretoria Eye Institute
Arcadia, Pretoria, 0083, South Africa
Seoul National University Hospital
Seoul, 110744, South Korea
Samsung Medical Center
Seoul, 135710, South Korea
Asan Medical Center
Seoul, 138736, South Korea
Eskisehir Osmangazi Universitesi Goz Hastaliklari Anabilim Dali
Meselik, Eskişehir, 26480, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim Arastirma Hastanesi Goz Hastaliklari
Pendik, Istanbul, 34890, Turkey (Türkiye)
Celal Bayar Universitesi Tip Fakultesi Goz Hastaliklari Anabilim Dali
Manisa, 45030, Turkey (Türkiye)
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
Queen Alexandra Hospital
Cosham, PO6 3LY, United Kingdom
Princess Alexandra Eye Pavilion
Edinburgh, EH3 9HA, United Kingdom
James Paget University Hosp NHS Foundation Trust
Great Yarmouth, NR31 6LA, United Kingdom
St Paul's Eye Unit Royal Liverpool&Broadgreen, NHS Trust
Liverpool, L7 8XP, United Kingdom
Aintree University Hospital NHS Foundation Trust
Liverpool, L9 7AL, United Kingdom
ICORG
London, 153-173, United Kingdom
In Patient Pharmacy, Ground Floor, Lambeth Wing St Thomas' Hospital
London, SE1 7EH, United Kingdom
Peterborough City Hospital Research and Development Department
Peterborough, PE39GZ, United Kingdom
Related Publications (3)
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.
PMID: 36378864DERIVEDMedeiros 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.
PMID: 35643967DERIVEDBacharach J, Tatham A, Ferguson G, Belalcazar S, Thieme H, Goodkin ML, Chen MY, Guo Q, Liu J, Robinson MR, Bejanian M, Wirta DL; ARTEMIS 2 Study Group. Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2). Drugs. 2021 Nov;81(17):2017-2033. doi: 10.1007/s40265-021-01624-9. Epub 2021 Nov 1.
PMID: 34724172DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Margot Goodkin
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2014
First Posted
September 26, 2014
Study Start
December 15, 2014
Primary Completion
October 25, 2018
Study Completion
July 22, 2020
Last Updated
July 28, 2021
Results First Posted
July 28, 2021
Record last verified: 2021-06