Clinical trial NCT03891446: Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
Official title: An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in Patients With Open Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: Open-Angle Glaucoma
Ocular Hypertension
Bimatoprost
DURYSTA
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-03-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.


Eligibility criteria: Inclusion Criteria:

* Participants who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and received Bimatoprost SR.
* Participants who completed (or exited early from) the open-label Phase 4 ARGOS study with no ongoing safety concerns, and received DURYSTA.

Exclusion Criteria:

* Female participants who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study.
* Concurrent or anticipated enrollment in another investigational drug or device study during the present study.
* Any condition which would preclude the participant's ability to comply with study requirements, including completion of the study.
* Participants who were randomized to receive timolol eye drops in the study eye (control group) during the Phase 3 Bimatoprost Studies 192024-091 and -092.
* For patients from the ARGOS lead-in study: history of prior incisional glaucoma surgeries and/or minimally invasive glaucoma surgical procedures in the study eye or treated fellow eye.

Primary outcomes:
measure: Duration of effect of Bimatoprost SR
timeFrame: Approximately 24 months
measure: Number of patients experiencing a treatment emergent adverse event
timeFrame: Approximately 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Trinity Research Group /ID# 240190
state: Alabama
city: Chandler
country: United States
facility: Arizona Eye Center /ID# 240239
state: Arizona
city: Phoenix
country: United States
facility: Arizona Glaucoma Specialists /ID# 240212
state: Arizona
city: Prescott
country: United States
facility: M&M Eye Institute /ID# 240236
state: Arizona
city: Sun City
country: United States
facility: Walman Eye Center /ID# 240255
state: Arizona
city: Culver City
country: United States
facility: Angeles Eye Institute /ID# 250397
state: California
city: Irvine
country: United States
facility: Lakeside Vision Center /ID# 240204
state: California
city: La Jolla
country: United States
facility: Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196
state: California
city: Newport Beach
country: United States
facility: The Eye Research Foundation /ID# 240186
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates Inc. /ID# 248912
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group /ID# 240291
state: California
city: Redding
country: United States
facility: The Clinical Trials Network (CTNx) /ID# 240284
state: California
city: Sacramento
country: United States
facility: Sacramento Eye Consultants /ID# 240263
state: California
city: San Francisco
country: United States
facility: Pacific Eye Associates /ID# 240234
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates /ID# 240221
state: California
city: Colorado Springs
country: United States
facility: Colorado Eye Institute /ID# 248910
state: Colorado
city: Coral Springs
country: United States
facility: Specialty Retina Center /ID# 240254
state: Florida
city: Crystal River
country: United States
facility: Nature Coast Clinical Research - Crystal River /ID# 240334
state: Florida
city: Delray Beach
country: United States
facility: Bruce Segal, MD /ID# 240292
state: Florida
city: Fort Myers
country: United States
facility: Eye Associates of Fort Meyers /ID# 240218
state: Florida
city: Jacksonville
country: United States
facility: Levenson Eye Associates Inc. /ID# 240209
state: Florida
city: Miami
country: United States
facility: MedEye Associates /ID# 240333
state: Florida
city: Tamarac
country: United States
facility: Logan Ophthalmic Research Inc. /ID# 240280
state: Florida
city: Tampa
country: United States
facility: International Research Center /ID# 240346
state: Florida
city: Tampa
country: United States
facility: University of South Florida /ID# 250980
state: Florida
city: Atlanta
country: United States
facility: Emory University /ID# 240328
state: Georgia
city: Roswell
country: United States
facility: Coastal Research Associates /ID# 240192
state: Georgia
city: Bedford Park
country: United States
facility: Chicago Eye Specialists /ID# 240270
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago /ID# 250981
state: Illinois
city: Elmhurst
country: United States
facility: Kovach Eye Institute /ID# 250442
state: Illinois
city: Indianapolis
country: United States
facility: IN Univ School of Medicine /ID# 240294
state: Indiana
city: Louisville
country: United States
facility: The Eye Care Institute /ID# 240289
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University /ID# 240327
state: Louisiana
city: Winchester
country: United States
facility: Clinical Eye Research of Boston LLC /ID# 240203
state: Massachusetts
city: Fraser
country: United States
facility: Fraser Eye Center /ID# 240245
state: Michigan
city: Chesterfield
country: United States
facility: Midwest Vision Research Foundation at Pepose Vision Institute /ID# 250402
state: Missouri
city: Saint Louis
country: United States
facility: Tekwani Vision Center /ID# 240220
state: Missouri
city: Dover
country: United States
facility: Eye Associates of North Jersey /ID# 250445
state: New Jersey
city: Livingston
country: United States
facility: Glaucoma Care Center /ID# 250978
state: New Jersey
city: Newark
country: United States
facility: Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 240181
state: New Jersey
city: Albuquerque
country: United States
facility: Eye Associates of New Mexico /ID# 240216
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Hospital /ID# 240324
state: New York
city: Oceanside
country: United States
facility: Ophthalmic Consultants Long Island /ID# 240211
state: New York
city: Rochester
country: United States
facility: Rochester Ophthalmological Group PC /ID# 240290
state: New York
city: Slingerlands
country: United States
facility: Glaucoma associates/consultants of the capital region /ID# 240195
state: New York
city: Asheville
country: United States
facility: Asheville Eye Associates /ID# 240202
state: North Carolina
city: Belmont
country: United States
facility: Charlotte Eye,Ear,Nose Throat /ID# 240339
state: North Carolina
city: Elizabeth City
country: United States
facility: Albemarle Clinical Trials LLC /ID# 240219
state: North Carolina
city: Winston-Salem
country: United States
facility: James D Branch MD /ID# 240188
state: North Carolina
city: Fargo
country: United States
facility: Bergstrom Eye Research LLC /ID# 240257
state: North Dakota
city: Oklahoma City
country: United States
facility: Oklahoma Eye Surgeons /ID# 250430
state: Oklahoma
city: Portland
country: United States
facility: Legacy Devers Eye Institute /ID# 240210
state: Oregon
city: Cranberry Township
country: United States
facility: Scott and Christie and Associates /ID# 240189
state: Pennsylvania
city: Memphis
country: United States
facility: Eye Specialty Group /ID# 240241
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Eye Institute /ID# 252659
state: Tennessee
city: Smyrna
country: United States
facility: Advancing Vision Research /ID# 240288
state: Tennessee
city: Austin
country: United States
facility: Keystone Research LTD /ID# 240185
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates /ID# 240340
state: Texas
city: Mission
country: United States
facility: DCT Shah Eye Research Institut /ID# 240306
state: Texas
city: Plano
country: United States
facility: Plano Office /ID# 240243
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center /ID# 240238
state: Texas
city: San Antonio
country: United States
facility: Eye associates /ID# 240265
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates /ID# 240208
state: Texas
city: Falls Church
country: United States
facility: Emerson Clinical Research Institute. LLC /ID# 240274
state: Virginia
city: Lynchburg
country: United States
facility: Piedmont Eye Center /ID# 240187
state: Virginia
city: Roanoke
country: United States
facility: Vistar Eye Center /ID# 240198
state: Virginia
city: Caba
country: Argentina
facility: Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Clinica Privada de Ojos /ID# 240272
state: Buenos Aires
city: Pilar
country: Argentina
facility: Hospital Universitario Austral /ID# 240331
state: Buenos Aires
city: Rosario
country: Argentina
facility: Oftalmología Global /ID# 240244
state: Santa Fe
city: Mendoza
country: Argentina
facility: Oftar Mendoza /ID# 240308
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 240312
state: Vlaams-Brabant
city: Campinas
country: Brazil
facility: Clinica De Oftalmologia Nova Campinas /ID# 240271
state: Sao Paulo
city: Osasco
country: Brazil
facility: Hospital Oftalmologico Medicina dos Olhos /ID# 240277
state: Sao Paulo
city: Campo Grande
country: Brazil
facility: Hospital de Olhos de Mato Grosso Do Sul /ID# 240276
city: Sao Paulo
country: Brazil
facility: Hospital Sao Paulo /ID# 240278
city: Halifax
country: Canada
facility: Dalhousie University /ID# 240336
state: Nova Scotia
city: Mississauga
country: Canada
facility: Ophthalmic Consultant Centres /ID# 240205
state: Ontario
city: Medellin
country: Colombia
facility: Clinica de Oftalmologia Sandiego /ID# 240233
state: Antioquia
city: Bogota
country: Colombia
facility: Fundacion Oftalmologica Nacional /ID# 240226
state: Distrito Capital De Bogota
city: Bucaramanga
country: Colombia
facility: Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634
state: Santander
city: Pardubice
country: Czechia
facility: Ocni klinika Pardubice /ID# 240347
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup /ID# 240330
state: Hovedstaden
city: Cairo
country: Egypt
facility: Ain Shams University Hospital /ID# 240338
city: Cairo
country: Egypt
facility: Bostan Diagnostic Eye Center /ID# 240268
city: Bordeaux CEDEX
country: France
facility: CHU Bordeaux - Hopital Pellegrin /ID# 240316
state: Gironde
city: Ecully
country: France
facility: Centre Ophtalmologique Pôle Vision /ID# 240256
city: Dusseldorf
country: Germany
facility: Internationale Innovative Ophthalmochirurgie /ID# 240232
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
facility: Universitaetsklinikum Magdeburg /ID# 240314
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong /ID# 240283
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 240332
state: H_efa
city: Haifa
country: Israel
facility: Bnai Zion Medical Center /ID# 240297
state: H_efa
city: Haifa
country: Israel
facility: The Lady Davis Carmel Medical Center /ID# 240293
state: H_efa
city: Naharia
country: Israel
facility: Galilee Medical Center /ID# 251967
state: HaTsafon
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 240311
state: Tel-Aviv
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia /ID# 240310
state: Umbria
city: Catania
country: Italy
facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 240305
city: Chieti
country: Italy
facility: Azienda Sanitaria Locale (ASL) Chieti /ID# 240217
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana /ID# 240301
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 240262
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 240286
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 240335
city: Wellington
country: New Zealand
facility: Capital Eye Specialists /ID# 240259
city: Lima
country: Peru
facility: Centro Oftalmologico Macula Diagnostico and Tratamiento /ID# 240269
city: Makati City
country: Philippines
facility: Asian Eye Institute /ID# 240213
city: Makati City
country: Philippines
facility: Asian Eye Institute /ID# 240214
city: Makati City
country: Philippines
facility: Peregrine Eye and Laser Institute /ID# 240260
city: Gdansk
country: Poland
facility: Optimum Profesorskie Centrum Okulistyki Sp. z o.o. /ID# 240307
state: Pomorskie
city: Bydgoszcz
country: Poland
facility: OFTALMIKA Sp. z o.o. /ID# 240201
city: Lublin
country: Poland
facility: Klinika Diagnostyki i Mikrochirurgii Jaskry /ID# 240258
city: Olsztyn
country: Poland
facility: Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 240248
city: Novosibirsk
country: Russian Federation
facility: S. Fyodorov Eye Microsurgery Federal State Institution /ID# 240251
city: Omsk
country: Russian Federation
facility: Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 240253
city: Singapore
country: Singapore
facility: Singapore National Eye Centre /ID# 240224
city: Pretoria
country: South Africa
facility: Pretoria Eye Institute - Private Practice /ID# 240223
state: Gauteng
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia /ID# 240322
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos /ID# 240303
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena /ID# 240325
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital /ID# 240194
city: Pathumthani
country: Thailand
facility: Thammasat University Hospital /ID# 240231
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University Medical School /ID# 240225
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240296
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust /ID# 240351
city: Edinburgh
country: United Kingdom
facility: Duplicate_NHS Lothian /ID# 240318
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: