Clinical trial NCT02250651: Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official title: The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-09-26
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2)
timeFrame: Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)
measure: IOP in the Study Eye at Week 2 (Hour 0)
timeFrame: Week 2 (Hour 0)
measure: IOP in the Study Eye at Week 2 (Hour 2)
timeFrame: Week 2 (Hour 2)
measure: IOP in the Study Eye at Week 6 (Hour 0)
timeFrame: Week 6 (Hour 0)
measure: IOP in the Study Eye at Week 6 (Hour 2)
timeFrame: Week 6 (Hour 2)
measure: IOP in the Study Eye at Week 12 (Hour 0)
timeFrame: Week 12 (Hour 0)
measure: IOP in the Study Eye at Week 12 (Hour 2)
timeFrame: Week 12 (Hour 2)
Secondary outcomes:
measure: Change From Baseline in IOP in the Study Eye
timeFrame: Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Eye Center South
state: Alabama
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Fayetteville
country: United States
facility: Vold Vision
state: Arkansas
city: Glendora
country: United States
facility: Mark B. Kislinger, MD, Inc.
state: California
city: Hemet
country: United States
facility: Inland Eye Specialists
state: California
city: Los Alamitos
country: United States
facility: Southern California Eye Physicians and Surgeons
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates, Inc.
state: California
city: Redding
country: United States
facility: Shasta Eye Medical Group, Inc.
state: California
city: San Francisco
country: United States
facility: University of California (UCSF) Department of Ophthalmology
state: California
city: San Luis Obispo
country: United States
facility: Pacific Eye Surgeons
state: California
city: Santa Maria
country: United States
facility: Shepard Eye Center
state: California
city: Torrance
country: United States
facility: East West Eye Institute
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Parker
country: United States
facility: Insight Vision Group
state: Colorado
city: Danbury
country: United States
facility: Danbury Eye Physicians and Surgeons PC
state: Connecticut
city: Cape Coral
country: United States
facility: Argus Research at Cape Coral Eye Center
state: Florida
city: Coral Springs
country: United States
facility: Specialty Retinal Center
state: Florida
city: Delray Beach
country: United States
facility: Bruce A Segal, M.D.
state: Florida
city: Fort Myers
country: United States
facility: Eye Associates of Fort Myers
state: Florida
city: Gainesville
country: United States
facility: Eye Clinic at Shands Medical Plaza
state: Florida
city: Palm Beach Gardens
country: United States
facility: Bascom Palmer Eye Institute, University of Miami
state: Florida
city: Sarasota
country: United States
facility: Center for Sight
state: Florida
city: South Miami
country: United States
facility: MedEye Associates
state: Florida
city: Atlanta
country: United States
facility: Emory University Eye Center
state: Georgia
city: Rock Island
country: United States
facility: Virdi Eye Clinic
state: Illinois
city: Louisville
country: United States
facility: Kentuckiana Institute for Eye Research at Bennett & Bloom Eye Centers White House Office Complex
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine, Wilmer Eye Institute
state: Maryland
city: Winchester
country: United States
facility: Clinical Eye Research of Boston, Co.
state: Massachusetts
city: Saint Louis
country: United States
facility: Tekwani Vision Center
state: Missouri
city: Newark
country: United States
facility: Rutgers-New Jersey Medical School
state: New Jersey
city: Albuquerque
country: United States
facility: Eye Associates of New Mexico
state: New Mexico
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Poughkeepsie
country: United States
facility: Alterman, Modi & Wolter
state: New York
city: Wantagh
country: United States
facility: South Shore Eye Care, LLP
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose & Throat Associates, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: James D. Branch, MD
state: North Carolina
city: Fargo
country: United States
facility: Bergstrom Eye and Laser Clinic
state: North Dakota
city: Portland
country: United States
facility: Legacy Good Samaritan Hospital - Devers Eye Institute
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Eye Center, P.C.
state: Pennsylvania
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Scheie Eye Institute, Department of Ophthalmology, University of Pennsylvania
state: Pennsylvania
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Alkek Eye Center
state: Texas
city: Mission
country: United States
facility: DCT-Shah Research, LLC dba Discovery ClinicalTrials
state: Texas
city: Plano
country: United States
facility: Key Whitman Eye Center
state: Texas
city: Roanoke
country: United States
facility: Vistar Eye Center
state: Virginia
city: Bellevue
country: United States
facility: Specialty Eyecare Centre
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee valley Hospital & Clinics, Clinical research department
state: Washington
city: Racine
country: United States
facility: The Eye Centers of Racine and Kenosha
state: Wisconsin
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Oftalmologico de Buenos Aires Oftalmos
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires - Hospital
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Clinica Privada de Ojos
state: Buenos Aires
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
state: Buenos Aires
city: Rosario
country: Argentina
facility: Centro Medico Oftalmologia Global
state: Santa Fe
city: Rosario
country: Argentina
facility: Centro Médico Grupo Laser Visión
state: Santa Fe
city: Ciudad Autónoma de BuenosAires
country: Argentina
facility: Organización Médica de Investigación
city: Mendoza
country: Argentina
facility: Oftar Centro Privado de Oftalmologia
city: Calgary
country: Canada
facility: ACS Crichton Prof. Corp
state: Alberta
city: Halifax
country: Canada
facility: Nova Scotia Health Authority, Department of Ophthalmology & Visual Sciences
state: Nova Scotia
city: Barrie
country: Canada
facility: Trimed Eye Center
state: Ontario
city: Concord
country: Canada
facility: Uptown Eye Specialists
state: Ontario
city: Kingston
country: Canada
facility: Galen Eye Centre
state: Ontario
city: Mississauga
country: Canada
facility: Ophthalmic Consultant Centres Inc
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Boisbriand
country: Canada
facility: Institut De L'Oeil Des Laurentides
state: Quebec
city: Drummondville
country: Canada
facility: Clinique d' ophtalmologie Dr Saurel
state: Quebec
city: Montreal
country: Canada
facility: Bellevue Clinic
state: Quebec
city: Sherbrooke
country: Canada
facility: GOGiunta Ophtalmologie
state: Quebec
city: Medellin
country: Colombia
facility: Clinica de Oftalmologia Sandiego S.A.
state: Antioquia
city: Bogota
country: Colombia
facility: Fundación Oftalmologica Nacional Fundonal
state: Distrito Capital De Bogota
city: Floridablanca
country: Colombia
facility: Fundacion Oftalmologica de Santander Foscal
state: Santander
city: Cali
country: Colombia
facility: Instituto de Investigaciones, Centro Médico Imbanaco de Cali S.A.
city: Brno
country: Czechia
facility: Ocni klinika
state: Jihlavska
city: Hradec Kralove
country: Czechia
facility: Nemocnicni Lekarna
state: Sokolska
city: Prague
country: Czechia
facility: Ocni klinika Pardubice
city: Shibīn al-Kawm
country: Egypt
facility: Menoufia University Hospital
state: Cairo
city: Cairo
country: Egypt
facility: Al Kasr Al Ainy Cairo University Hospital
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
city: Regensburg
country: Germany
facility: Klinikum der Universität Regensburg
state: Bayern
city: Ahaus
country: Germany
facility: Augen Zentrum Nordwest
state: Nordrhein-Westfalen
city: Munster
country: Germany
facility: Augenärzte am St. Franziskus-Hospital
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
facility: Universitätsklinik Magdeburg
state: Sachsen-Anhalt
city: Mainz
country: Germany
facility: Klinisches Studienzentrum
city: Chieti
country: Italy
facility: Università degli Studi G. D'Annunzio Chieti-Pescara
state: Abruzzo
city: Milano
country: Italy
facility: Azienda Ospedaliera-Polo Universitario San Paolo
state: Lombardia
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
state: Sicilia
city: Pisa
country: Italy
facility: Oculistica Universitaria Università Degli Studi di Pisa - Ospedale di Cisanello Pisa
state: Toscana
city: Milano
country: Italy
facility: Unità Operativa di Oculistica Ospedale San Raffaele S.r.l.
city: Perugia
country: Italy
facility: Ospedale Santa Maria Della Misericordia
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Cheras
country: Malaysia
facility: Hospital Kuala Lumpur Jalan Pahang, Department of Opthalmology
state: Kuala Lumpur
city: Wellington
country: New Zealand
facility: Capital Eye Specialists
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore National Eye Centre
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Bloemfontein
country: South Africa
facility: Horizon Eye Care Centre
state: Free State
city: Arcadia
country: South Africa
facility: Pretoria Eye Institute
state: Pretoria
city: Meselik
country: Turkey
facility: Eskisehir Osmangazi Universitesi Goz Hastaliklari Anabilim Dali
state: Eskisehir
city: Pendik
country: Turkey
facility: Marmara Universitesi Pendik Egitim Arastirma Hastanesi Goz Hastaliklari
state: Istanbul
city: Manisa
country: Turkey
facility: Celal Bayar Universitesi Tip Fakultesi Goz Hastaliklari Anabilim Dali
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Cosham
country: United Kingdom
facility: Queen Alexandra Hospital
city: Edinburgh
country: United Kingdom
facility: Princess Alexandra Eye Pavilion
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hosp NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: St Paul's Eye Unit Royal Liverpool&Broadgreen, NHS Trust
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: ICORG
city: London
country: United Kingdom
facility: In Patient Pharmacy, Ground Floor, Lambeth Wing St Thomas' Hospital
city: Peterborough
country: United Kingdom
facility: Peterborough City Hospital Research and Development Department
Study officials:
affiliation: Allergan
name: Margot Goodkin
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.