Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension

Last updated: May 29, 2020
Sponsor: Allergan
Overall Status: Completed

Phase

3

Condition

Circulation Disorders

Vascular Diseases

Glaucoma

Treatment

N/A

Clinical Study ID

NCT02247804
192024-091
2014-003037-26
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

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

Exclusion

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 thestudy duration

  • History of glaucoma surgery

Study Design

Total Participants: 594
Study Start date:
December 15, 2014
Estimated Completion Date:
July 19, 2019

Connect with a study center

  • empty

    Melbourne, Victoria
    Australia

    Site Not Available

  • Vision Eye Institute Chatswood

    Chatsworth, New South Wales
    Australia

    Site Not Available

  • Melbourne Eye Specialists

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • Waverley Eye Clinic

    Glen Waverley, Vctoria 3150
    Australia

    Site Not Available

  • Marsden Eye Specialists, Parramatta

    Paramatta, New South Wales
    Australia

    Site Not Available

  • Preston Eye Clinic

    Preston, Victoria 3072
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales
    Australia

    Site Not Available

  • Gosford & Wyong Eye Surgery

    Wyong, New South Wales
    Australia

    Site Not Available

  • University of Graz

    Graz, A-8036
    Austria

    Site Not Available

  • Universitaetsklinik fuer Augenheilkunde und Optometrie

    Salburg, 5020
    Austria

    Site Not Available

  • Universitaetsklinik fuer Augenheilkunde und Optometrie

    Salzburg, 5020
    Austria

    Site Not Available

  • University of Vienna

    Vienna, 1090
    Austria

    Site Not Available

  • Augenheilkunde und Optometrie Vinzenz

    Wien, 1130
    Austria

    Site Not Available

  • Academisch Zeikenhuis Sint Jan

    Brugges, B-8000
    Belgium

    Site Not Available

  • Cliniquie Universitaires Saint-Luc (U.C.L.)

    Brussels, B-1200
    Belgium

    Site Not Available

  • University Hospitals Leuven

    Leuven, B-3000
    Belgium

    Site Not Available

  • CHU Sart Tilman

    Liege, 4000
    Belgium

    Site Not Available

  • Universidade Federal de Goias

    Goiania, Goias 74180-010
    Brazil

    Site Not Available

  • Elo Oftalmologistas Associados

    Belo Horizonte, Minas Gerais 30140-090
    Brazil

    Site Not Available

  • Hospital de Clinicas da Universidade Federal do Paraná

    Curitiba, Parana 80010-180
    Brazil

    Site Not Available

  • Nova Campinas Oftalmologia

    Campinas, Sao Paulo 13010-111
    Brazil

    Site Not Available

  • Hospital Medicina dos Olhos

    Centro, Osasco, Sao Paulo 06010-130
    Brazil

    Site Not Available

  • Hospital Medicina dos Olhos

    Osasco, Sao Paulo 06010-130
    Brazil

    Site Not Available

  • Hospital das Clínicas - Faculdade de Medicina

    CEP, 14049-900
    Brazil

    Site Not Available

  • Hospital de Olhos MS

    Rio Verde, 79002-075
    Brazil

    Site Not Available

  • Escola Paulista de Medicina

    Sao Paulo, 04023-062
    Brazil

    Site Not Available

  • Hospital das Clínicas - Faculdade de Medicina

    Sao Paulo, 14049-900
    Brazil

    Site Not Available

  • Hospital Regional Rancagua

    Rancagua, Hospital Regional Rancagua
    Chile

    Site Not Available

  • Fundación Oftalmológica Los Andes

    Santiago,
    Chile

    Site Not Available

  • National Taiwan University Hospital

    Taipei, Taiwan 10048
    China

    Site Not Available

  • Glostrup Hospital

    Glostrup, 2600
    Denmark

    Site Not Available

  • Glostrup Hospital

    Glostrup Copenhagen, 2600
    Denmark

    Site Not Available

  • Copenhagen University

    Roskilde, DK-4000
    Denmark

    Site Not Available

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, Gironde 33076
    France

    Site Not Available

  • Centre Hospitalier Regional Jean Minjoz

    Besancon Cedex, 25030
    France

    Site Not Available

  • CHU Gabriel Montpied

    Clermont-Ferrand Cedex 01, 63003
    France

    Site Not Available

  • CHU Dijon - Bocage Central

    Dijon, 21033
    France

    Site Not Available

  • CHU de Grenoble

    Grenoble, 38700
    France

    Site Not Available

  • Centre Hospitalier Regional Universitaire Dupuytren

    Limoges Cedex, 87042
    France

    Site Not Available

  • Hospital de la Croix-Rousse

    Lyon, 69437
    France

    Site Not Available

  • Hopital St Roch

    Nice Cedex, 06000
    France

    Site Not Available

  • Hopital Necker Service d'Ophtalmologie

    Paris, 75015
    France

    Site Not Available

  • Polyclinique de l'atlantique

    St. Herblain, 44800
    France

    Site Not Available

  • Centre Hospitalier

    Tarves, 65013
    France

    Site Not Available

  • Centre Hospitalier Regional Universitaire Bretonneau

    Tours Cedex F, 37000
    France

    Site Not Available

  • Hong Kong Eye Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • The University of Hong Kong

    Hong Kong,
    Hong Kong

    Site Not Available

  • Uzsoki Hospital - Ophthalmology

    Budapest, 1145
    Hungary

    Site Not Available

  • University Med. School of Debrecen

    Debrecen, 4012
    Hungary

    Site Not Available

  • Ganglion Medical Center

    Pecs, H-7621
    Hungary

    Site Not Available

  • University of Szeged Szent-Gyorgyi Albert Clinical Center

    Szeged, H-6720
    Hungary

    Site Not Available

  • Markusovszky Korhaz

    Szombathely, H-9700
    Hungary

    Site Not Available

  • Zala Megyei Kórház

    Zalaegerszeg, H-8900
    Hungary

    Site Not Available

  • Haemek Medical Center

    Afula, 1834111
    Israel

    Site Not Available

  • Barzilai Medical Center

    Ashkelon, 78278
    Israel

    Site Not Available

  • Soroka Medical Center

    Beer Sheva, 84101
    Israel

    Site Not Available

  • Assaf Harofeh Medical Center

    Beer-Yaakov, 70300
    Israel

    Site Not Available

  • Bnai Zion M.C.

    Haifa, 31048
    Israel

    Site Not Available

  • Carmel Medical Center

    Haifa, 34362
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa, 31096
    Israel

    Site Not Available

  • Wolfson Hospital

    Holon, 58100
    Israel

    Site Not Available

  • Meir Hospital

    Kfar-Saba,
    Israel

    Site Not Available

  • Rabin Medical Center Beilinson Hospital

    Petach Tiqva, 49100
    Israel

    Site Not Available

  • Kaplan Medical Center

    Rehovot, 76100
    Israel

    Site Not Available

  • Sheba Medical Center

    Tel Aviv, 68125
    Israel

    Site Not Available

  • Centro Oftalmológico Mácula Diagnóstico y Tratamiento

    Lima, Lima 27
    Peru

    Site Not Available

  • American Eye Center

    Makati City, National Capital Region 1229
    Philippines

    Site Not Available

  • Asian Eye Institute

    Makati, 1200
    Philippines

    Site Not Available

  • Makati Medical Center

    Makati, 1229
    Philippines

    Site Not Available

  • Pacific Eyecare & Laser Institute

    Makati, 1200
    Philippines

    Site Not Available

  • empty

    Manila,
    Philippines

    Site Not Available

  • Prywatna Klinika Okulistyczna OFTALMIKA

    Bydgoszcz, 85-631
    Poland

    Site Not Available

  • Optimum Profesorskie Centrum Okulistyki

    Gdansk, 80-211
    Poland

    Site Not Available

  • Specjalistyczna Praktyka Lekarska

    Katowice, 43-300
    Poland

    Site Not Available

  • Klinika Okulistyczna Jasne Blonia

    Lodz, 90-134-
    Poland

    Site Not Available

  • Public Clinical Hospital No. 1

    Lublin, 20-079
    Poland

    Site Not Available

  • Osrodek Chirurgii Oka

    Naleczow, 24-140
    Poland

    Site Not Available

  • ZOZ OKO- TEST Poradnia Okulistyczna

    Nowy Targ, 34-400
    Poland

    Site Not Available

  • Diagnostic and Microsurgery Center of the Eye LENS

    Olsztyn, 10-424
    Poland

    Site Not Available

  • Klinika Okulistyki WIML

    Warsaw, 01-755
    Poland

    Site Not Available

  • Retina Sp. z o.o

    Warsaw, 01-364
    Poland

    Site Not Available

  • Klinika Okulistyki WIML

    Warsazawa, 01-755
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny

    Warszawa, 01-755
    Poland

    Site Not Available

  • Uniwersyteck Szpital Kliniczny

    Wroclaw, 50-368
    Poland

    Site Not Available

  • Hospital General de Jerez de la Frontera

    Jerez de la Frontera, Cadiz 11407
    Spain

    Site Not Available

  • Centro de Ojos de La Coruña

    A Coruna, 15006
    Spain

    Site Not Available

  • Hospital de Torrevieja

    Alicante, 03186
    Spain

    Site Not Available

  • Hospital General de Catalunya

    Barcelona, 08195
    Spain

    Site Not Available

  • Institut Catala de la Retina

    Barcelona, 08017
    Spain

    Site Not Available

  • Institut Clinic d'Oftalmologia

    Barcelona, 08006
    Spain

    Site Not Available

  • ICQO

    Bilbao, 48006
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofía

    Cordoba, 14004
    Spain

    Site Not Available

  • Clinica Oftalmologica Gil Pina

    Huelva, 21004
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28004
    Spain

    Site Not Available

  • Universidad de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Sevilla, 41071
    Spain

    Site Not Available

  • Hospital General

    Valencia, 46017
    Spain

    Site Not Available

  • Hospital Universitario Rio Hortega

    Valladolid, 47012
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

  • Centre Ophtalmologique de Florissant Gordana

    Geneva, 1200
    Switzerland

    Site Not Available

  • Hôpitaux Universitaires de Genève, HUG

    Geneve, 1211
    Switzerland

    Site Not Available

  • Hopital Ophtalmique Jules Gonin

    Lausanne, 1000
    Switzerland

    Site Not Available

  • Stadtspital Triemli Ophthalmology

    Zurich, 8063
    Switzerland

    Site Not Available

  • Buddhist Tzu Chi General Hospital (BTCGH)

    Chung-Yang Road, Hualien 970
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei City, Republic of China 114
    Taiwan

    Site Not Available

  • Buddhist Tzu Chi General Hospital (BTCGH)

    Hualien, 970
    Taiwan

    Site Not Available

  • Kaohsiung Veterans General Hospital

    Kaohsiung, 81362
    Taiwan

    Site Not Available

  • Arizona Glaucoma Specialists

    Phoenix, Arizona 85050
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Lugene Eye Institute

    Glendale, California 91205
    United States

    Site Not Available

  • Lakeside Vision Center

    Irvine, California 92604
    United States

    Site Not Available

  • Hamilton Glaucoma Center, Shiley Eye Center UCSD

    La Jolla, California 92037
    United States

    Site Not Available

  • Atlantis Eye Care

    Long Beach, California 90808
    United States

    Site Not Available

  • Glaucoma Institute of Beverly Hills

    Los Angeles, California 90048
    United States

    Site Not Available

  • Montebello Medical Eye Center Inc.

    Montebello, California 90640
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94303
    United States

    Site Not Available

  • Foothill Eye Institute

    Pasadena, California 91107
    United States

    Site Not Available

  • Martel Eye Medical Group

    Rancho Cordova, California 95670
    United States

    Site Not Available

  • Grutzmacher, Lewis and Sierra, Inc.

    Sacramento, California 95815
    United States

    Site Not Available

  • West Coast Eye Care Associates

    San Diego, California 92115
    United States

    Site Not Available

  • Pacific Eye Associates

    San Francisco, California 94115
    United States

    Site Not Available

  • Eye Associates of Colorado Springs

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Palm Beach Eye Center, INC

    Atlantis, Florida 33461
    United States

    Site Not Available

  • Nature Coast Clinical Research

    Crystal River, Florida 34429
    United States

    Site Not Available

  • Rand Eye Institute

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Levenson Eye Associates

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • Center for Excellence in Eye Care

    Miami, Florida 33176
    United States

    Site Not Available

  • Mid Florida Eye Center

    Mount Dora, Florida 32757
    United States

    Site Not Available

  • East Florida Eye Institute

    Stuart, Florida 34994
    United States

    Site Not Available

  • International Research Center

    Tampa, Florida 33603
    United States

    Site Not Available

  • Coastal Research Associates, LLC

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Chicago Eye Specialists

    Chicago, Illinois 60619
    United States

    Site Not Available

  • Chicago Cornea Consultants, Ltd.

    Highland Park, Illinois 60035
    United States

    Site Not Available

  • Indiana University School of Medicine

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Heart of America Eye Care PA

    Shawnee, Kansas 66204
    United States

    Site Not Available

  • Heart of America Eye Care PA

    Shawnee Mission, Kansas 66204
    United States

    Site Not Available

  • Tulane Medical Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Eye Doctors of Washington

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • MedRACS, LLC

    Quincy, Massachusetts 02169
    United States

    Site Not Available

  • Ocular Immunology and Uveitis Foundation

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Glaucoma Center of Michigan

    Southfield, Michigan 48034
    United States

    Site Not Available

  • Minnesota Eye Constultants, P.A.

    Bloomington, Minnesota 55431
    United States

    Site Not Available

  • Lifelong Vision Foundation

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Moyes Eye Center, PC

    Kansas City, Missouri 64154
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Eyesight Ophthalmic Services, PA

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Northern New Jersey Eye Institute P.A.

    South Orange, New Jersey 07079
    United States

    Site Not Available

  • Eyecare Ophthalmology Associates, PC

    Bethage, New York 11714
    United States

    Site Not Available

  • Eyecare Ophthalmology Associates, PC

    Bethpage, New York 11714
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • New York Eye and Ear Infirmary of Mount Sinai

    New York, New York 10003
    United States

    Site Not Available

  • Fichte Endl & Elmer Eyecare

    Niagara Falls, New York 14304
    United States

    Site Not Available

  • Rochester Ophthalmological Group PC

    Rochester, New York 14618
    United States

    Site Not Available

  • 2000 North Village Avenue

    Rockville Centre, New York 11570
    United States

    Site Not Available

  • Glaucoma Consultants of the Capital Region

    Slingelands, New York 12159
    United States

    Site Not Available

  • Glaucoma Consultants of the Capital Region

    Slingerlands, New York 12159
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx, New York 10467
    United States

    Site Not Available

  • 8 Medical Park Drive

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Mundorf Eye Center

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Albemarle Clinical Trials, LLC

    Elizabeth City, North Carolina 27909
    United States

    Site Not Available

  • University Hospitals of Cleveland

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • The Ohio State University Havener Eye Institute

    Columbus, Ohio 43212
    United States

    Site Not Available

  • Drs Fine Hoffman & Sims, LLC

    Eugene, Oregon 97401
    United States

    Site Not Available

  • The Eye Center of Central PA

    Allenwood, Pennsylvania 17810
    United States

    Site Not Available

  • Laurel Eye Clinic

    Brookville, Pennsylvania 15825
    United States

    Site Not Available

  • Asian Eye Institute

    Lancaster, Pennsylvania 17601
    United States

    Site Not Available

  • Wills Eye Institute - Glaucoma Research Center

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Associates in Ophthalmology

    Pittsburgh, Pennsylvania 15219
    United States

    Site Not Available

  • Carolinas Centers for Sight PC

    Florence, South Carolina 29501
    United States

    Site Not Available

  • VRF Eye Specialty Group

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Nashville Vision Associates

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Keystone Research, LTD

    Austin, Texas 78731
    United States

    Site Not Available

  • Glaucoma Associates of Texas

    Dallas, Texas 75231
    United States

    Site Not Available

  • The Cataract, Glaucoma & Refractive Surgery Center

    El Paso, Texas 79902
    United States

    Site Not Available

  • Houston Eye Associates

    Houston, Texas 77025
    United States

    Site Not Available

  • Focal Point Vision

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Medical Center Ophthalmology Associates

    San Antonio, Texas 78240
    United States

    Site Not Available

  • R and R Eye Research, LLC

    San Antonio, Texas 78234
    United States

    Site Not Available

  • Hammond Eye Institute

    Logan, Utah 84341
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • See Clearly Vision Group

    McLean, Virginia 22102
    United States

    Site Not Available

  • Virginia Eye Consultants

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Site Not Available

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