Clinical trial NCT02247804: Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants 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: 2014-09-25
Enrollment: 594
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 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.


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 in either eye within the first 52 weeks of the study duration
* History of glaucoma surgery

Primary outcomes:
measure: Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2)
timeFrame: Baseline (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 (Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Glaucoma Specialists
state: Arizona
city: Glendale
country: United States
facility: Lugene Eye Institute
state: California
city: Irvine
country: United States
facility: Lakeside Vision Center
state: California
city: La Jolla
country: United States
facility: Hamilton Glaucoma Center, Shiley Eye Center UCSD
state: California
city: Long Beach
country: United States
facility: Atlantis Eye Care
state: California
city: Los Angeles
country: United States
facility: Glaucoma Institute of Beverly Hills
state: California
city: Montebello
country: United States
facility: Montebello Medical Eye Center Inc.
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Pasadena
country: United States
facility: Foothill Eye Institute
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Sacramento
country: United States
facility: Grutzmacher, Lewis and Sierra, Inc.
state: California
city: San Francisco
country: United States
facility: Pacific Eye Associates
state: California
city: Colorado Springs
country: United States
facility: Eye Associates of Colorado Springs
state: Colorado
city: Atlantis
country: United States
facility: Palm Beach Eye Center, INC
state: Florida
city: Crystal River
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Levenson Eye Associates
state: Florida
city: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
city: Tampa
country: United States
facility: International Research Center
state: Florida
city: Roswell
country: United States
facility: Coastal Research Associates, LLC
state: Georgia
city: Chicago
country: United States
facility: Chicago Eye Specialists
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Shawnee Mission
country: United States
facility: Heart of America Eye Care PA
state: Kansas
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Chevy Chase
country: United States
facility: Eye Doctors of Washington
state: Maryland
city: Quincy
country: United States
facility: MedRACS, LLC
state: Massachusetts
city: Waltham
country: United States
facility: Ocular Immunology and Uveitis Foundation
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Bloomington
country: United States
facility: Minnesota Eye Constultants, P.A.
state: Minnesota
city: Chesterfield
country: United States
facility: Lifelong Vision Foundation
state: Missouri
city: Kansas City
country: United States
facility: Moyes Eye Center, PC
state: Missouri
city: South Orange
country: United States
facility: Northern New Jersey Eye Institute P.A.
state: New Jersey
city: Bethpage
country: United States
facility: Eyecare Ophthalmology Associates, PC
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: New York Eye and Ear Infirmary of Mount Sinai
state: New York
city: Rochester
country: United States
facility: Rochester Ophthalmological Group PC
state: New York
city: Rockville Centre
country: United States
facility: 2000 North Village Avenue
state: New York
city: Slingerlands
country: United States
facility: Glaucoma Consultants of the Capital Region
state: New York
city: Asheville
country: United States
facility: 8 Medical Park Drive
state: North Carolina
city: Elizabeth City
country: United States
facility: Albemarle Clinical Trials, LLC
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Havener Eye Institute
state: Ohio
city: Eugene
country: United States
facility: Drs Fine Hoffman & Sims, LLC
state: Oregon
city: Philadelphia
country: United States
facility: Wills Eye Institute - Glaucoma Research Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Associates in Ophthalmology
state: Pennsylvania
city: Florence
country: United States
facility: Carolinas Centers for Sight PC
state: South Carolina
city: Memphis
country: United States
facility: VRF Eye Specialty Group
state: Tennessee
city: Nashville
country: United States
facility: Nashville Vision Associates
state: Tennessee
city: Austin
country: United States
facility: Keystone Research, LTD
state: Texas
city: Dallas
country: United States
facility: Glaucoma Associates of Texas
state: Texas
city: El Paso
country: United States
facility: The Cataract, Glaucoma & Refractive Surgery Center
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: San Antonio
country: United States
facility: Focal Point Vision
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Chatsworth
country: Australia
facility: Vision Eye Institute Chatswood
city: Fitzroy
country: Australia
facility: Melbourne Eye Specialists
city: Glen Waverley
country: Australia
facility: Waverley Eye Clinic
city: Paramatta
country: Australia
facility: Marsden Eye Specialists, Parramatta
city: Preston
country: Australia
facility: Preston Eye Clinic
city: Graz
country: Austria
facility: University of Graz
city: Vienna
country: Austria
facility: University of Vienna
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Liege
country: Belgium
facility: CHU Sart Tilman
city: Goiania
country: Brazil
facility: Universidade Federal de Goias
state: Goias
city: Belo Horizonte
country: Brazil
facility: Elo Oftalmologistas Associados
state: Minas Gerais
city: Campinas
country: Brazil
facility: Nova Campinas Oftalmologia
state: Sao Paulo
city: Osasco
country: Brazil
facility: Hospital Medicina dos Olhos
state: Sao Paulo
city: Rio Verde
country: Brazil
facility: Hospital de Olhos MS
city: Sao Paulo
country: Brazil
facility: Escola Paulista de Medicina
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas - Faculdade de Medicina
city: Glostrup
country: Denmark
facility: Glostrup Hospital
city: Hong Kong
country: Hong Kong
facility: Hong Kong Eye Hospital
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
city: Pecs
country: Hungary
facility: Ganglion Medical Center
city: Szombathely
country: Hungary
facility: Markusovszky Korhaz
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Kórház
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Haifa
country: Israel
facility: Bnai Zion M.C.
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Lima
country: Peru
facility: Centro Oftalmológico Mácula Diagnóstico y Tratamiento
city: Makati
country: Philippines
facility: Asian Eye Institute
city: Makati
country: Philippines
facility: Pacific Eyecare & Laser Institute
city: Makati
country: Philippines
facility: Makati Medical Center
city: Bydgoszcz
country: Poland
facility: Prywatna Klinika Okulistyczna OFTALMIKA
city: Gdansk
country: Poland
facility: Optimum Profesorskie Centrum Okulistyki
city: Lublin
country: Poland
facility: Public Clinical Hospital No. 1
city: Nowy Targ
country: Poland
facility: ZOZ OKO- TEST Poradnia Okulistyczna
city: Olsztyn
country: Poland
facility: Diagnostic and Microsurgery Center of the Eye LENS
city: Warsaw
country: Poland
facility: Retina Sp. z o.o
city: Warsaw
country: Poland
facility: Klinika Okulistyki WIML
city: Warszawa
country: Poland
facility: Uniwersytecki Szpital Kliniczny
city: Wroclaw
country: Poland
facility: Uniwersyteck Szpital Kliniczny
city: Barcelona
country: Spain
facility: Institut Clinic d'Oftalmologia
city: Barcelona
country: Spain
facility: Institut Catala de la Retina
city: Barcelona
country: Spain
facility: Hospital General de Catalunya
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital General
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Hualien
country: Taiwan
facility: Buddhist Tzu Chi General Hospital (BTCGH)
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Allergan
name: Marina Bejanian
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.