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

PHASE3CompletedINTERVENTIONAL
Enrollment

594

Participants

Timeline

Start Date

December 15, 2014

Primary Completion Date

February 19, 2018

Study Completion Date

July 19, 2019

Conditions
Glaucoma, Open-AngleOcular Hypertension
Interventions
DRUG

Bimatoprost SR

Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.

DRUG

Active Comparator: Timolol 0.5%

Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.

OTHER

Sham: Applicator Without Needle

Sham administered on Day 1, Week 16, and Week 32.

DRUG

Timolol Vehicle (placebo)

Timolol vehicle administered once in the morning and once in the evening for up to 20 months.

Trial Locations (106)

970

Buddhist Tzu Chi General Hospital (BTCGH), Hualien City

1090

University of Vienna, Vienna

1200

Asian Eye Institute, Makati

Pacific Eyecare & Laser Institute, Makati

1229

Makati Medical Center, Makati

2600

Glostrup Hospital, Glostrup Municipality

4000

CHU Sart Tilman, Liège

10003

New York Eye and Ear Infirmary of Mount Sinai, New York

10467

Montefiore Medical Center, The Bronx

11570

2000 North Village Avenue, Rockville Centre

11714

Eyecare Ophthalmology Associates, PC, Bethpage

12159

Glaucoma Consultants of the Capital Region, Slingerlands

14004

Hospital Universitario Reina Sofía, Córdoba

14618

Rochester Ophthalmological Group PC, Rochester

15219

Associates in Ophthalmology, Pittsburgh

19107

Wills Eye Institute - Glaucoma Research Center, Philadelphia

20815

Eye Doctors of Washington, Chevy Chase

24502

Piedmont Eye Center, Lynchburg

26506

West Virginia University, Morgantown

27909

Albemarle Clinical Trials, LLC, Elizabeth City

28004

Hospital Clinico San Carlos, Madrid

28803

8 Medical Park Drive, Asheville

29501

Carolinas Centers for Sight PC, Florence

30076

Coastal Research Associates, LLC, Roswell

31048

Bnai Zion M.C., Haifa

31096

Rambam Medical Center, Haifa

32204

Levenson Eye Associates, Jacksonville

33461

Palm Beach Eye Center, INC, Atlantis

33603

International Research Center, Tampa

34362

Carmel Medical Center, Haifa

34429

Nature Coast Clinical Research, Crystal River

34994

East Florida Eye Institute, Stuart

37205

Nashville Vision Associates, Nashville

38120

VRF Eye Specialty Group, Memphis

41071

Hospital Universitario Virgen Macarena, Seville

43212

The Ohio State University Havener Eye Institute, Columbus

44106

University Hospitals of Cleveland, Cleveland

46017

Hospital General, Valencia

46202

Indiana University School of Medicine, Indianapolis

47012

Hospital Universitario Rio Hortega, Valladolid

48109

University of Michigan, Ann Arbor

50009

Hospital Universitario Miguel Servet, Zaragoza

55431

Minnesota Eye Constultants, P.A., Bloomington

60619

Chicago Eye Specialists, Chicago

63017

Lifelong Vision Foundation, Chesterfield

64154

Moyes Eye Center, PC, Kansas City

66204

Heart of America Eye Care PA, Shawnee Mission

70112

Tulane Medical Center, New Orleans

75231

Glaucoma Associates of Texas, Dallas

77025

Houston Eye Associates, Houston

78229

Focal Point Vision, San Antonio

78234

R and R Eye Research, LLC, San Antonio

78240

Medical Center Ophthalmology Associates, San Antonio

78278

Barzilai Medical Center, Ashkelon

78731

Keystone Research, LTD, Austin

79902

The Cataract, Glaucoma & Refractive Surgery Center, El Paso

80907

Eye Associates of Colorado Springs, Colorado Springs

81362

Kaohsiung Veterans General Hospital, Kaohsiung City

85050

Arizona Glaucoma Specialists, Phoenix

90048

Glaucoma Institute of Beverly Hills, Los Angeles

90640

Montebello Medical Eye Center Inc., Montebello

90808

Atlantis Eye Care, Long Beach

91107

Foothill Eye Institute, Pasadena

91205

Lugene Eye Institute, Glendale

92037

Hamilton Glaucoma Center, Shiley Eye Center UCSD, La Jolla

92604

Lakeside Vision Center, Irvine

94115

Pacific Eye Associates, San Francisco

94303

Stanford University, Palo Alto

95670

Martel Eye Medical Group, Rancho Cordova

95815

Grutzmacher, Lewis and Sierra, Inc., Sacramento

97401

Drs Fine Hoffman & Sims, LLC, Eugene

02169

MedRACS, LLC, Quincy

02451

Ocular Immunology and Uveitis Foundation, Waltham

07079

Northern New Jersey Eye Institute P.A., South Orange

New South Wales

Vision Eye Institute Chatswood, Chatsworth

Marsden Eye Specialists, Parramatta, Paramatta

Victoria 3065

Melbourne Eye Specialists, Fitzroy

Vctoria 3150

Waverley Eye Clinic, Glen Waverley

Victoria 3072

Preston Eye Clinic, Preston

A-8036

University of Graz, Graz

B-3000

University Hospitals Leuven, Leuven

74180-010

Universidade Federal de Goias, Goiânia

30140-090

Elo Oftalmologistas Associados, Belo Horizonte

13010-111

Nova Campinas Oftalmologia, Campinas

06010-130

Hospital Medicina dos Olhos, Osasco

79002-075

Hospital de Olhos MS, Rio Verde

04023-062

Escola Paulista de Medicina, São Paulo

14049-900

Hospital das Clínicas - Faculdade de Medicina, São Paulo

Unknown

Hong Kong Eye Hospital, Hong Kong

The University of Hong Kong, Hong Kong

H-7621

Ganglion Medical Center, Pécs

H-9700

Markusovszky Korhaz, Szombathely

H-8900

Zala Megyei Kórház, Zalaegerszeg

Lima 27

Centro Oftalmológico Mácula Diagnóstico y Tratamiento, Lima

85-631

Prywatna Klinika Okulistyczna OFTALMIKA, Bydgoszcz

80-211

Optimum Profesorskie Centrum Okulistyki, Gdansk

20-079

Public Clinical Hospital No. 1, Lublin

34-400

ZOZ OKO- TEST Poradnia Okulistyczna, Nowy Targ

10-424

Diagnostic and Microsurgery Center of the Eye LENS, Olsztyn

01-364

Retina Sp. z o.o, Warsaw

01-755

Klinika Okulistyki WIML, Warsaw

Uniwersytecki Szpital Kliniczny, Warsaw

50-368

Uniwersyteck Szpital Kliniczny, Wroclaw

08006

Institut Clinic d'Oftalmologia, Barcelona

08017

Institut Catala de la Retina, Barcelona

08195

Hospital General de Catalunya, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Allergan

INDUSTRY

NCT02247804 - Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension | Biotech Hunter | Biotech Hunter