Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

Last updated: February 9, 2024
Sponsor: AbbVie
Overall Status: Active - Enrolling

Phase

3

Condition

Glaucoma

Vascular Diseases

Stress

Treatment

Standard of Care

Bimatoprost SR

Clinical Study ID

NCT03891446
1698-302-007
2023-504601-36-00
2018-003597-26
  • Ages > 18
  • All Genders

Study 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

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 studywith no ongoing safety concerns, and received DURYSTA.

Exclusion

Exclusion Criteria:

  • Female participants who are pregnant, nursing, or planning a pregnancy, or who are ofchildbearing potential and not using a reliable means of contraception during thestudy.
  • Concurrent or anticipated enrollment in another investigational drug or device studyduring the present study.
  • Any condition which would preclude the participant's ability to comply with studyrequirements, 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 glaucomasurgeries and/or minimally invasive glaucoma surgical procedures in the study eye ortreated fellow eye.

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Standard of Care
Phase: 3
Study Start date:
March 27, 2019
Estimated Completion Date:
August 07, 2026

Connect with a study center

  • Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247

    Caba, Buenos Aires 1122
    Argentina

    Site Not Available

  • Clinica Privada de Ojos /ID# 240272

    Mar del Plata, Buenos Aires 7600
    Argentina

    Site Not Available

  • Hospital Universitario Austral /ID# 240331

    Pilar, Buenos Aires 1629
    Argentina

    Site Not Available

  • Oftar Centro Privado de Oftalmologia

    Mendoza City, Mendoza 5500
    Argentina

    Site Not Available

  • Oftalmología Global /ID# 240244

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Consultorio Oftalmologico Dr. Fabian Lerner

    Buenos Aires,
    Argentina

    Site Not Available

  • Oftar Mendoza /ID# 240308

    Mendoza, 1019
    Argentina

    Site Not Available

  • Oftalmologia Global

    Santa Fe, S2000DSK
    Argentina

    Site Not Available

  • University of Graz

    Graz, A-8036
    Austria

    Site Not Available

  • Universitair Ziekenhuis Leuven /ID# 240312

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • CHU Sart Tilman

    Liege, 4000
    Belgium

    Site Not Available

  • Hospital das Clinicas da Universidade Federal de Goiás /ID# 240344

    Goiania, Goias 74605-020
    Brazil

    Site Not Available

  • Clinica De Oftalmologia Nova Campinas /ID# 240271

    Campinas, Sao Paulo 13092-108
    Brazil

    Site Not Available

  • Hospital Oftalmologico Medicina dos Olhos /ID# 240277

    Osasco, Sao Paulo 0601-8180
    Brazil

    Site Not Available

  • Hospital de Olhos de Mato Grosso Do Sul /ID# 240276

    Campo Grande, 79002-075
    Brazil

    Site Not Available

  • Hospital Sao Paulo /ID# 240278

    Sao Paulo, 04023-062
    Brazil

    Site Not Available

  • Dalhousie University /ID# 240336

    Halifax, Nova Scotia B3H 3A7
    Canada

    Site Not Available

  • St Joseph's Healthcare

    Hamilton, Ontario L8G 5E4
    Canada

    Site Not Available

  • Ophthalmic Consultant Centres /ID# 240205

    Mississauga, Ontario L4W 1W9
    Canada

    Site Not Available

  • Montreal Glaucoma Institute

    Montreal, Quebec H1V 1G5
    Canada

    Site Not Available

  • Clinica de Oftalmologia Sandiego /ID# 240233

    Medellin, Antioquia 050016
    Colombia

    Site Not Available

  • Fundacion Oftalmologica de Santander - FOSCAL

    Santander, Bucaramanga 681004
    Colombia

    Site Not Available

  • Fundacion Oftalmologica Nacional /ID# 240226

    Bogota, Distrito Capital De Bogota 110231
    Colombia

    Site Not Available

  • Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634

    Bucaramanga, Santander 681004
    Colombia

    Site Not Available

  • Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634

    Floridablanca, Santander 681004
    Colombia

    Site Not Available

  • University Hospital Brno

    Brno, 62500
    Czechia

    Site Not Available

  • Fakultni Nemocnice Hradec Kralove

    Hradec Kralove, 500 05
    Czechia

    Site Not Available

  • Ocni klinika Pardubice /ID# 240347

    Pardubice, 530 02
    Czechia

    Site Not Available

  • Rigshospitalet Glostrup /ID# 240330

    Glostrup, Hovedstaden 2600
    Denmark

    Site Not Available

  • Menoufia University Hospital

    Shibin Al Kawm, Al Minufiyah 32511
    Egypt

    Site Not Available

  • Ain Shams University Hospital /ID# 240338

    Cairo,
    Egypt

    Site Not Available

  • Bostan Diagnostic Eye Center /ID# 240268

    Cairo,
    Egypt

    Site Not Available

  • CHU Bordeaux - Hopital Pellegrin /ID# 240316

    Bordeaux CEDEX, Gironde 33076
    France

    Site Not Available

  • CHU Nice -Hopital Pasteur /ID# 240299

    Nice CEDEX 1, Provence-Alpes-Cote-d Azur 06002
    France

    Site Not Available

  • CHU Bordeaux - Hopital Pellegrin /ID# 240316

    Bordeaux, 33000
    France

    Site Not Available

  • Centre Ophtalmologique Pôle Vision /ID# 240256

    Ecully, 69130
    France

    Site Not Available

  • CHU de Limoges - Service d'Ophthalmologie

    Limoges, 87042
    France

    Site Not Available

  • CHU de NICE

    Nice, 01069
    France

    Site Not Available

  • CHU Purpan

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Internationale Innovative Ophthalmochirurgie /ID# 240232

    Dusseldorf, Nordrhein-Westfalen 40212
    Germany

    Site Not Available

  • Charite-Universtitaetsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Universitaetsklinikum Magdeburg /ID# 240314

    Magdeburg, 39120
    Germany

    Site Not Available

  • Universitatsklinikum Munster

    Munster, 48149
    Germany

    Site Not Available

  • The Chinese University of Hong Kong /ID# 240283

    Hong Kong,
    Hong Kong

    Site Not Available

  • Bnai Zion Medical Center /ID# 240297

    Haifa, H_efa 3339419
    Israel

    Site Not Available

  • Rambam Health Care Campus /ID# 240332

    Haifa, H_efa 3109601
    Israel

    Site Not Available

  • The Lady Davis Carmel Medical Center /ID# 240293

    Haifa, H_efa 34362
    Israel

    Site Not Available

  • Galilee Medical Center /ID# 251967

    Naharia, HaTsafon 2210001
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center /ID# 240311

    Tel Aviv, Tel-Aviv 6423906
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center /ID# 240311

    Tel Aviv-Yafo, Tel-Aviv 6423906
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Azienda Ospedaliera di Perugia /ID# 240310

    Perugia, Umbria 06129
    Italy

    Site Not Available

  • A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 240305

    Catania, 95123
    Italy

    Site Not Available

  • Azienda Sanitaria Locale (ASL) Chieti /ID# 240217

    Chieti, 66100
    Italy

    Site Not Available

  • IRCCS Azienda Ospedaliera Universitaria San Martino

    Genoa, 16132
    Italy

    Site Not Available

  • Ospedale San Raffaele S.r.l. - PPDS

    Milan, 20132
    Italy

    Site Not Available

  • U.O. Oculistica Dipartimento di Medicina e Chirurgia. Univ.

    Parma, 43100
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana /ID# 240301

    Pisa, 56126
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 240301

    Pisa, 56126
    Italy

    Site Not Available

  • University of Udine - Azienda Sanitaria Universitaria Integrata di Udine

    Udine, 33100
    Italy

    Site Not Available

  • Seoul National University Hospital

    Ihwa-dong, Seoul 110-744
    Korea, Republic of

    Site Not Available

  • Asan Medical Center /ID# 240286

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center /ID# 240335

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital /ID# 240262

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Capital Eye Specialist - Wellington

    Te Aro, Wellington N 6011
    New Zealand

    Site Not Available

  • Capital Eye Specialists /ID# 240259

    Wellington, 6011
    New Zealand

    Site Not Available

  • Centro Oftalmologico Macula Diagnostico and Tratamiento /ID# 240269

    Lima, LIMA 27
    Peru

    Site Not Available

  • Asian Eye Institute /ID# 240213

    Makati City, 1200
    Philippines

    Site Not Available

  • Asian Eye Institute /ID# 240214

    Makati City, 1200
    Philippines

    Site Not Available

  • Peregrine Eye and Laser Institute /ID# 240260

    Makati City, 1209
    Philippines

    Site Not Available

  • Optimum Profesorskie Centrum Okulistyki Sp. z o.o. /ID# 240307

    Gdansk, Pomorskie 80-809
    Poland

    Site Not Available

  • Optinum Profesorskie Centrum Okulistyki /ID# 240307

    Gdansk, Pomorskie 80-809
    Poland

    Site Not Available

  • OFTALMIKA Sp. z o.o. /ID# 240201

    Bydgoszcz, 85-631
    Poland

    Site Not Available

  • Klinika Diagnostyki i Mikrochirurgii Jaskry /ID# 240258

    Lublin, 20-079
    Poland

    Site Not Available

  • Centrum Diagnostyki i Mikrochirurgii Oka - LENS dr n. med. Slawomir Zalewski /ID# 240248

    Olsztyn, 10-424
    Poland

    Site Not Available

  • Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 240248

    Olsztyn, 10-424
    Poland

    Site Not Available

  • S. Fyodorov Eye Microsurgery Federal State Institution /ID# 240251

    Novosibirsk, 630071
    Russian Federation

    Site Not Available

  • Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 240253

    Omsk, 644024
    Russian Federation

    Site Not Available

  • Samara State Medical University

    Samara, 410012
    Russian Federation

    Site Not Available

  • St. Petersburg State Medical University

    St. Petersburg, 197022
    Russian Federation

    Site Not Available

  • Singapore National Eye Centre /ID# 240224

    Singapore, 168251
    Singapore

    Site Not Available

  • Pretoria Eye Institute - Private Practice /ID# 240223

    Pretoria, Gauteng 0083
    South Africa

    Site Not Available

  • Dr Lynette Venter

    Bloemfontein, 9301
    South Africa

    Site Not Available

  • Dr Lynette Venter

    Westdene, 9301
    South Africa

    Site Not Available

  • Hospital Universitario Reina Sofia /ID# 240322

    Cordoba, 14004
    Spain

    Site Not Available

  • Hospital Clinico Universitario San Carlos /ID# 240303

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena /ID# 240325

    Sevilla, 41009
    Spain

    Site Not Available

  • Hospital General Universitario de Valencia

    Valencia, 46017
    Spain

    Site Not Available

  • Thammasat University Hospital

    Khlongluang, Pathum Thani 12120
    Thailand

    Site Not Available

  • Maharaj Nakorn Chiang Mai Hospital /ID# 240194

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Thammasat University Hospital /ID# 240231

    Pathumthani, 12120
    Thailand

    Site Not Available

  • Eskisehir Osmangazi University Medical School /ID# 240225

    Eskisehir, 26480
    Turkey

    Site Not Available

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240287

    Istanbul, 34899
    Turkey

    Site Not Available

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240296

    Istanbul, 34899
    Turkey

    Site Not Available

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • Cambridge University Hospitals NHS Foundation Trust /ID# 240351

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Royal Derby Hospital

    Derby, DE22 3NE
    United Kingdom

    Site Not Available

  • Duplicate_NHS Lothian /ID# 240318

    Edinburgh, EH3 9HE
    United Kingdom

    Site Not Available

  • Addenbrookes Hospital

    Huntingdon, PE29 6NT
    United Kingdom

    Site Not Available

  • Moorfields Eye Hospital NHS Foundation Trust /ID# 240329

    London, EC1V 2PD
    United Kingdom

    Site Not Available

  • Trinity Research Group /ID# 240190

    Dothan, Alabama 36301
    United States

    Site Not Available

  • Arizona Eye Center /ID# 240239

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Arizona Glaucoma Specialists /ID# 240212

    Phoenix, Arizona 85050-4265
    United States

    Site Not Available

  • M&M Eye Institute /ID# 240236

    Prescott, Arizona 86301
    United States

    Site Not Available

  • Walman Eye Center /ID# 240255

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Retina Institute of California Medical Group

    Arcadia, California 91007
    United States

    Site Not Available

  • Angeles Eye Institute /ID# 250397

    Culver City, California 90232
    United States

    Site Not Available

  • Lugene Eye Institute

    Glendale, California 91204
    United States

    Site Not Available

  • Lakeside Vision Center /ID# 240204

    Irvine, California 92604
    United States

    Site Not Available

  • Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196

    La Jolla, California 92093
    United States

    Site Not Available

  • The Eye Research Foundation /ID# 240186

    Newport Beach, California 92663-3637
    United States

    Site Not Available

  • California Eye Specialists Medical Group Inc. /ID# 250979

    Pasadena, California 91107
    United States

    Site Not Available

  • North Bay Eye Associates Inc. /ID# 248912

    Petaluma, California 94954-2387
    United States

    Site Not Available

  • Martel Eye Medical Group /ID# 240291

    Rancho Cordova, California 95670-2968
    United States

    Site Not Available

  • The Clinical Trials Network (CTNx) /ID# 240284

    Redding, California 96001
    United States

    Site Not Available

  • Sacramento Eye Consultants /ID# 240263

    Sacramento, California 95815
    United States

    Site Not Available

  • Pacific Eye Associates /ID# 240234

    San Francisco, California 94115
    United States

    Site Not Available

  • Wolstan & Goldberg Eye Associates /ID# 240221

    Torrance, California 90505
    United States

    Site Not Available

  • Colorado Eye Institute /ID# 248910

    Colorado Springs, Colorado 80924-7003
    United States

    Site Not Available

  • Specialty Retina Center /ID# 240254

    Coral Springs, Florida 33067
    United States

    Site Not Available

  • Nature Coast Clinical Research - Crystal River /ID# 240334

    Crystal River, Florida 34429
    United States

    Site Not Available

  • Bruce Segal, MD /ID# 240292

    Delray Beach, Florida 33484-6540
    United States

    Site Not Available

  • Eye Associates of Fort Meyers /ID# 240218

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • Levenson Eye Associates Inc. /ID# 240209

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • The Eye Institute for Medicine and Surgery

    Melbourne, Florida 32904
    United States

    Site Not Available

  • MedEye Associates /ID# 240333

    Miami, Florida 33143
    United States

    Site Not Available

  • MedEye Associates

    South Miami, Florida 33143
    United States

    Site Not Available

  • Logan Ophthalmic Research Inc. /ID# 240280

    Tamarac, Florida 33321
    United States

    Site Not Available

  • International Research Center /ID# 240346

    Tampa, Florida 33603
    United States

    Site Not Available

  • University of South Florida /ID# 250980

    Tampa, Florida 33612
    United States

    Site Not Available

  • Specialty Retina Center

    Weston, Florida 33326
    United States

    Site Not Available

  • Emory University /ID# 240328

    Atlanta, Georgia 30322-1013
    United States

    Site Not Available

  • Coastal Research Associates /ID# 240192

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Chicago Eye Specialists /ID# 240270

    Bedford Park, Illinois 60638
    United States

    Site Not Available

  • University of Illinois at Chicago /ID# 250981

    Chicago, Illinois 60607
    United States

    Site Not Available

  • University of Illinois at Chicago Illinois Eye and Ear Infirmary /ID# 250981

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Kovach Eye Institute /ID# 250442

    Elmhurst, Illinois 60126-2821
    United States

    Site Not Available

  • IN Univ School of Medicine /ID# 240294

    Indianapolis, Indiana 46202-2884
    United States

    Site Not Available

  • The Eye Care Institute /ID# 240289

    Louisville, Kentucky 40206-1738
    United States

    Site Not Available

  • Tulane University /ID# 240327

    New Orleans, Louisiana 70112-2699
    United States

    Site Not Available

  • Clinical Eye Research of Boston LLC /ID# 240203

    Winchester, Massachusetts 01890
    United States

    Site Not Available

  • Fraser Eye Center /ID# 240245

    Fraser, Michigan 48026
    United States

    Site Not Available

  • Midwest Vision Research Foundation at Pepose Vision Institute /ID# 250402

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Tekwani Vision Center /ID# 240220

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • Eye Associates of North Jersey /ID# 250445

    Dover, New Jersey 07801-1629
    United States

    Site Not Available

  • Glaucoma Care Center /ID# 250978

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 240181

    Newark, New Jersey 07103-2425
    United States

    Site Not Available

  • Eye Associates of New Mexico /ID# 240216

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Montefiore Hospital /ID# 240324

    Bronx, New York 10467-2404
    United States

    Site Not Available

  • Ophthalmic Consultants Long Island

    Lynbrook, New York 11563
    United States

    Site Not Available

  • New York Presbyterian Hospital Weill Cornell Medical Center /ID# 240324

    New York, New York 10065
    United States

    Site Not Available

  • Ophthalmic Consultants Long Island /ID# 240211

    Oceanside, New York 11572
    United States

    Site Not Available

  • Rochester Ophthalmological Group PC /ID# 240290

    Rochester, New York 14618-2616
    United States

    Site Not Available

  • Glaucoma associates/consultants of the capital region /ID# 240195

    Slingerlands, New York 12159
    United States

    Site Not Available

  • Asheville Eye Associates /ID# 240202

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Charlotte Eye,Ear,Nose Throat /ID# 240339

    Belmont, North Carolina 28012
    United States

    Site Not Available

  • Charlotte Eye Ear Nose & Throat Associates, PA

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Albemarle Clinical Trials LLC /ID# 240219

    Elizabeth City, North Carolina 27909
    United States

    Site Not Available

  • James D Branch MD /ID# 240188

    Winston-Salem, North Carolina 27101
    United States

    Site Not Available

  • Bergstrom Eye Research LLC /ID# 240257

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Oklahoma Eye Surgeons /ID# 250430

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Legacy Devers Eye Institute /ID# 240210

    Portland, Oregon 97210
    United States

    Site Not Available

  • Scott and Christie and Associates /ID# 240189

    Cranberry Township, Pennsylvania 16066
    United States

    Site Not Available

  • Carolinas Center for Sight, PC

    Florence, South Carolina 29501
    United States

    Site Not Available

  • Eye Specialty Group /ID# 240241

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Vanderbilt Eye Institute /ID# 252659

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Advancing Vision Research /ID# 240288

    Smyrna, Tennessee 37167
    United States

    Site Not Available

  • Keystone Research LTD /ID# 240185

    Austin, Texas 78731-4203
    United States

    Site Not Available

  • Glaucoma Associates of Texas

    Dallas, Texas 75231
    United States

    Site Not Available

  • Houston Eye Associates /ID# 240340

    Houston, Texas 77025
    United States

    Site Not Available

  • DCT Shah Eye Research Institut /ID# 240306

    Mission, Texas 78572
    United States

    Site Not Available

  • Plano Office /ID# 240243

    Plano, Texas 75093
    United States

    Site Not Available

  • Eye associates /ID# 240265

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Medical Center Ophthalmology Associates /ID# 240208

    San Antonio, Texas 78240-1502
    United States

    Site Not Available

  • San Antonio Eye Center /ID# 240238

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Emerson Clinical Research Institute. LLC /ID# 240274

    Falls Church, Virginia 22046
    United States

    Site Not Available

  • Piedmont Eye Center /ID# 240187

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • Vistar Eye Center /ID# 240198

    Roanoke, Virginia 24011
    United States

    Site Not Available

  • West Virginia University Eye Institute

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • The Eye Centers of Racine & Kenosha

    Racine, Wisconsin 53405
    United States

    Site Not Available

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