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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma, Open-Angle
• Intervention / Treatment: Drug: Bimatoprost SR; Drug: Active Comparator: Timolol 0.5%; Other: Sham: Applicator Without Needle; Drug: Timolol Vehicle (placebo)

• Study Type: Interventional
• Enrollment (Actual): 528
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autónoma de BuenosAires, Argentina, C1015ABO
    • Organizacion Medica de Investigacion
  • Mendoza, Argentina, 5500
    • Oftar Centro Privado de Oftalmologia
  • Buenos Aires
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1120AAN
      • Instituto Oftalmologico de Buenos Aires Oftalmos
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1181ACH
      • Hospital Italiano de Buenos Aires - Hospital
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Clinica Privada de Ojos
    • Pilar, Buenos Aires, Argentina, B1629ODT
      • Hospital Universitario Austral
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Centro Medico Oftalmologia Global
    • Rosario, Santa Fe, Argentina, S2000AZH
      • Centro Médico Grupo Laser Visión
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3E-7M8
      • ACS Crichton Prof. Corp
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Nova Scotia Health Authority, Department of Ophthalmology & Visual Sciences
  • Ontario
    • Barrie, Ontario, Canada, L4M455
      • Trimed Eye Center
    • Concord, Ontario, Canada, L4K225
      • Uptown Eye Specialists
    • Kingston, Ontario, Canada, K7K 6Z6
      • Galen Eye Centre
    • Mississauga, Ontario, Canada, L4W1W9
      • Ophthalmic Consultant Centres Inc
    • Toronto, Ontario, Canada, M4N3M5
      • Sunnybrook Research Institute
  • Quebec
    • Boisbriand, Quebec, Canada, J7J 2BJ
      • Institut De L'Oeil Des Laurentides
    • Drummondville, Quebec, Canada, J2C 2C4
      • Clinique d' ophtalmologie Dr Saurel
    • Montreal, Quebec, Canada, H1V 1GS
      • Bellevue Clinic
    • Sherbrooke, Quebec, Canada, J1G 2V4
      • GOGiunta ophtalmologie
• Colombia
  • Cali, Colombia, 760001
    • Instituto de Investigaciones, Centro Médico Imbanaco de Cali S.A.
  • Antioquia
    • Medellin, Antioquia, Colombia, 0000
      • Clinica de Oftalmologia Sandiego S.A.
  • Distrito Capital De Bogota
    • Bogota, Distrito Capital De Bogota, Colombia, 110231
      • Fundación Oftalmologica Nacional Fundonal
  • Santander
    • Floridablanca, Santander, Colombia, 680004
      • Fundación Oftalmológica de Santander FOSCAL
• Czechia
  • Prague, Czechia, 53002
    • Ocni klinika Pardubice
  • Jihlavska
    • Brno, Jihlavska, Czechia, 62500
      • Ocni klinika
  • Sokolska
    • Hradec Kralove, Sokolska, Czechia, 50005
      • Nemocniční lékárna
• Egypt
  • Cairo, Egypt, 11566
    • Ain Shams University Hospital
  • Cairo, Egypt, 11562
    • Al Kasr Al Ainy Cairo University Hospital
  • Cairo
    • Shibīn al-Kawm, Cairo, Egypt, 32111
      • Menoufia university hospital
• Germany
  • Mainz, Germany, 55131
    • Klinisches Studienzentrum
  • Bayern
    • Regensburg, Bayern, Germany, 93053
      • Klinikum der Universität Regensburg
  • Nordrhein-Westfalen
    • Ahaus, Nordrhein-Westfalen, Germany, 48683
      • Augen Zentrum Nordwest
    • Munster, Nordrhein-Westfalen, Germany, 48145
      • Augenärzte am St. Franziskus-Hospital
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
      • Universitätsklinik Magdeburg
• Italy
  • Milano, Italy, 20132
    • Unità Operativa di Oculistica Ospedale San Raffaele S.r.l.
  • Perugia, Italy, 06156
    • Ospedale Santa Maria della Misericordia
  • Abruzzo
    • Chieti, Abruzzo, Italy, 66013
      • Università degli Studi G. D'Annunzio Chieti-Pescara
  • Lombardia
    • Milano, Lombardia, Italy, 20142
      • Azienda Ospedaliera-Polo Universitario San Paolo
  • Sicilia
    • Catania, Sicilia, Italy, 95123
      • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
  • Toscana
    • Pisa, Toscana, Italy, 56124
      • Oculistica Universitaria Università Degli Studi di Pisa - Ospedale di Cisanello Pisa
• Korea, Republic of
  • Seoul, Korea, Republic of, 110744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 138736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 135710
    • Samsung Medical Center
• Malaysia
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 50586
      • Hospital Kuala Lumpur Jalan Pahang, Department of Opthalmology
• New Zealand
  • Wellington, New Zealand, 06011
    • Capital Eye Specialists
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 529889
    • Changi General Hospital
  • Singapore, Singapore, 168751
    • Singapore National Eye Centre
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • Horizon Eye Care Centre
  • Pretoria
    • Arcadia, Pretoria, South Africa, 0083
      • Pretoria Eye Institute
• Turkey
  • Manisa, Turkey, 45030
    • Celal Bayar Universitesi Tip Fakultesi Goz Hastaliklari Anabilim Dali
  • Eskisehir
    • Meselik, Eskisehir, Turkey, 26480
      • Eskisehir Osmangazi Universitesi Goz Hastaliklari Anabilim Dali
  • Istanbul
    • Pendik, Istanbul, Turkey, 34890
      • Marmara Universitesi Pendik Egitim Arastirma Hastanesi Goz Hastaliklari
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Hospital
  • Cosham, United Kingdom, PO6 3LY
    • Queen Alexandra Hospital
  • Edinburgh, United Kingdom, EH3 9HA
    • Princess Alexandra Eye Pavilion
  • Great Yarmouth, United Kingdom, NR31 6LA
    • James Paget University Hosp NHS Foundation Trust
  • Liverpool, United Kingdom, L9 7AL
    • Aintree University Hospital NHS Foundation Trust
  • Liverpool, United Kingdom, L7 8XP
    • St Paul's Eye Unit Royal Liverpool&Broadgreen, NHS Trust
  • London, United Kingdom, 153-173
    • ICORG
  • London, United Kingdom, SE1 7EH
    • In Patient Pharmacy, Ground Floor, Lambeth Wing St Thomas' Hospital
  • Peterborough, United Kingdom, PE39GZ
    • Peterborough City Hospital Research and Development Department
• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Eye Center South
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Arizona Eye Center
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • Vold Vision
  • California
    • Glendora, California, United States, 91741
      • Mark B. Kislinger, MD, Inc.
    • Hemet, California, United States, 92545
      • Inland Eye Specialists
    • Los Alamitos, California, United States, 90720
      • Southern California Eye Physicians and Surgeons
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates, Inc.
    • Redding, California, United States, 96002
      • Shasta Eye Medical Group, Inc.
    • San Francisco, California, United States, 94143
      • University of California (UCSF) Department of Ophthalmology
    • San Luis Obispo, California, United States, 93401
      • Pacific Eye Surgeons
    • Santa Maria, California, United States, 93454
      • Shepard Eye Center
    • Torrance, California, United States, 90505
      • Wolstan & Goldberg Eye Associates
    • Torrance, California, United States, 90505
      • East West Eye Institute
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Parker, Colorado, United States, 80134
      • Insight Vision Group
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Eye Physicians and Surgeons PC
  • Florida
    • Cape Coral, Florida, United States, 33904
      • Argus Research at Cape Coral Eye Center
    • Coral Springs, Florida, United States, 33067
      • Specialty Retinal Center
    • Delray Beach, Florida, United States, 33484
      • Bruce A Segal, M.D.
    • Fort Myers, Florida, United States, 33901
      • Eye Associates of Fort Myers
    • Gainesville, Florida, United States, 32608
      • Eye Clinic at Shands Medical Plaza
    • Palm Beach Gardens, Florida, United States, 33418
      • Bascom Palmer Eye Institute, University of Miami
    • Sarasota, Florida, United States, 34239
      • Center for Sight
    • South Miami, Florida, United States, 33143-3693
      • MedEye Associates
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Eye Center
  • Illinois
    • Rock Island, Illinois, United States, 61201
      • Virdi Eye Clinic
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • Kentuckiana Institute for Eye Research at Bennett & Bloom Eye Centers White House Office Complex
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins School of Medicine, Wilmer Eye Institute
  • Massachusetts
    • Winchester, Massachusetts, United States, 01890
      • Clinical Eye Research of Boston, Co.
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • Tekwani Vision Center
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Rutgers-New Jersey Medical School
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Eye Associates of New Mexico
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
    • Poughkeepsie, New York, United States, 12603
      • Alterman, Modi & Wolter
    • Wantagh, New York, United States, 11793
      • South Shore Eye Care, LLP
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye Ear Nose & Throat Associates, PA
    • Winston-Salem, North Carolina, United States, 27101
      • James D. Branch, MD
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Bergstrom Eye and Laser Clinic
  • Oregon
    • Portland, Oregon, United States, 97210
      • Legacy Good Samaritan Hospital - Devers Eye Institute
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Valley Eye Center, P.C.
    • Cranberry Township, Pennsylvania, United States, 16006
      • Scott & Christie and Associates, PC
    • Philadelphia, Pennsylvania, United States, 19104
      • Scheie Eye Institute, Department of Ophthalmology, University of Pennsylvania
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
    • Houston, Texas, United States, 77030
      • Alkek Eye Center
    • Mission, Texas, United States, 78572
      • DCT-Shah Research, LLC dba Discovery ClinicalTrials
    • Plano, Texas, United States, 75093
      • Key Whitman Eye Center
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Vistar Eye Center
  • Washington
    • Bellevue, Washington, United States, 98004
      • Specialty Eyecare Centre
    • Wenatchee, Washington, United States, 98801
      • Wenatchee valley Hospital & Clinics, Clinical research department
  • Wisconsin
    • Racine, Wisconsin, United States, 53405
      • The Eye Centers of Racine and Kenosha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Bimatoprost SR; Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.; Drug: Active Comparator: Timolol 0.5%; Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.; Other: Sham: Applicator Without Needle; Sham administered on Day 1, Week 16, and Week 32.; Drug: Timolol Vehicle (placebo); Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Experimental: Bimatoprost SR 15 μg; 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.	Drug: Bimatoprost SR; Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.; Drug: Active Comparator: Timolol 0.5%; Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.; Other: Sham: Applicator Without Needle; Sham administered on Day 1, Week 16, and Week 32.; Drug: Timolol Vehicle (placebo); Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Active Comparator: Timolol 0.5%: Comparator; Both 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.	Drug: Active Comparator: Timolol 0.5%; Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.; Other: Sham: Applicator Without Needle; Sham administered on Day 1, Week 16, and Week 32.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in IOP in the Study Eye	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.	Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Margot Goodkin, Allergan

Publications and helpful links

General Publications

• 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.
• 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. 2022 Nov 15. doi: 10.1089/jop.2022.0137. Online ahead of print.
• Bacharach 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.

Helpful Links

• More Information

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2014
• Primary Completion (Actual): October 25, 2018
• Study Completion (Actual): July 22, 2020

Study Registration Dates

• First Submitted: September 23, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimate): September 26, 2014

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 6, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Timolol; Bimatoprost
• Other Study ID Numbers: 192024-092; 2014-003186-24 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No