Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension

PHASE3CompletedINTERVENTIONAL
Enrollment

528

Participants

Timeline

Start Date

December 15, 2014

Primary Completion Date

October 25, 2018

Study Completion Date

July 22, 2020

Conditions
Glaucoma, Open-AngleOcular Hypertension
Interventions
DRUG

Bimatoprost SR

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

OTHER

Sham: Applicator Without Needle

Sham administered 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.

DRUG

Timolol Vehicle (placebo)

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

Trial Locations (113)

2000

Centro Medico Oftalmologia Global, Rosario

5500

Oftar Centro Privado de Oftalmologia, Mendoza

7600

Clinica Privada de Ojos, Mar del Plata

9301

Horizon Eye Care Centre, Bloemfontein

10029

Mount Sinai School of Medicine, New York

11562

Al Kasr Al Ainy Cairo University Hospital, Cairo

11566

Ain Shams University Hospital, Cairo

11793

South Shore Eye Care, LLP, Wantagh

12603

Alterman, Modi & Wolter, Poughkeepsie

16006

Scott & Christie and Associates, PC, Cranberry Township

18104

Lehigh Valley Eye Center, P.C., Allentown

19104

Scheie Eye Institute, Department of Ophthalmology, University of Pennsylvania, Philadelphia

20132

Unità Operativa di Oculistica Ospedale San Raffaele S.r.l., Milan

20142

Azienda Ospedaliera-Polo Universitario San Paolo, Milan

21287

Johns Hopkins School of Medicine, Wilmer Eye Institute, Baltimore

24016

Vistar Eye Center, Roanoke

26480

Eskisehir Osmangazi Universitesi Goz Hastaliklari Anabilim Dali, Meselik

27101

James D. Branch, MD, Winston-Salem

28210

Charlotte Eye Ear Nose & Throat Associates, PA, Charlotte

30322

Emory University Eye Center, Atlanta

32111

Menoufia University Hospital, Shibīn al-Kawm

32608

Eye Clinic at Shands Medical Plaza, Gainesville

33067

Specialty Retinal Center, Coral Springs

33418

Bascom Palmer Eye Institute, University of Miami, Palm Beach Gardens

33484

Bruce A Segal, M.D., Delray Beach

33901

Eye Associates of Fort Myers, Fort Myers

33904

Argus Research at Cape Coral Eye Center, Cape Coral

34239

Center for Sight, Sarasota

34890

Marmara Universitesi Pendik Egitim Arastirma Hastanesi Goz Hastaliklari, Pendik

36301

Eye Center South, Dothan

39120

Universitätsklinik Magdeburg, Magdeburg

40215

Kentuckiana Institute for Eye Research at Bennett & Bloom Eye Centers White House Office Complex, Louisville

45030

Celal Bayar Universitesi Tip Fakultesi Goz Hastaliklari Anabilim Dali, Manisa

48145

Augenärzte am St. Franziskus-Hospital, Münster

48683

Augen Zentrum Nordwest, Ahaus

50005

Nemocnicni Lekarna, Hradec Králové

50586

Hospital Kuala Lumpur Jalan Pahang, Department of Opthalmology, Cheras

53002

Ocni klinika Pardubice, Prague

53405

The Eye Centers of Racine and Kenosha, Racine

55131

Klinisches Studienzentrum, Mainz

56124

Oculistica Universitaria Università Degli Studi di Pisa - Ospedale di Cisanello Pisa, Pisa

58103

Bergstrom Eye and Laser Clinic, Fargo

61201

Virdi Eye Clinic, Rock Island

62500

Ocni klinika, Brno

63128

Tekwani Vision Center, St Louis

66013

Università degli Studi G. D'Annunzio Chieti-Pescara, Chieti

72704

Vold Vision, Fayetteville

75093

Key Whitman Eye Center, Plano

77030

Alkek Eye Center, Houston

77555

University of Texas Medical Branch, Galveston

78572

DCT-Shah Research, LLC dba Discovery ClinicalTrials, Mission

80045

University of Colorado, Aurora

80134

Insight Vision Group, Parker

85224

Arizona Eye Center, Chandler

87109

Eye Associates of New Mexico, Albuquerque

90505

East West Eye Institute, Torrance

Wolstan & Goldberg Eye Associates, Torrance

90720

Southern California Eye Physicians and Surgeons, Los Alamitos

91741

Mark B. Kislinger, MD, Inc., Glendora

92545

Inland Eye Specialists, Hemet

92663

Eye Research Foundation, Newport Beach

93053

Klinikum der Universität Regensburg, Regensburg

93401

Pacific Eye Surgeons, San Luis Obispo

93454

Shepard Eye Center, Santa Maria

94143

University of California (UCSF) Department of Ophthalmology, San Francisco

94954

North Bay Eye Associates, Inc., Petaluma

95123

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele, Catania

96002

Shasta Eye Medical Group, Inc., Redding

97210

Legacy Good Samaritan Hospital - Devers Eye Institute, Portland

98004

Specialty Eyecare Centre, Bellevue

98801

Wenatchee valley Hospital & Clinics, Clinical research department, Wenatchee

110231

Fundación Oftalmologica Nacional Fundonal, Bogotá

110744

Seoul National University Hospital, Seoul

119074

National University Hospital, Singapore

135710

Samsung Medical Center, Seoul

138736

Asan Medical Center, Seoul

168751

Singapore National Eye Centre, Singapore

529889

Changi General Hospital, Singapore

680004

Fundacion Oftalmologica de Santander Foscal, Floridablanca

760001

Instituto de Investigaciones, Centro Médico Imbanaco de Cali S.A., Santiago de Cali

06810

Danbury Eye Physicians and Surgeons PC, Danbury

33143-3693

MedEye Associates, South Miami

01890

Clinical Eye Research of Boston, Co., Winchester

07103

Rutgers-New Jersey Medical School, Newark

C1120AAN

Instituto Oftalmologico de Buenos Aires Oftalmos, Ciudad Autónoma de Buenos Aires

C1181ACH

Hospital Italiano de Buenos Aires - Hospital, Ciudad Autónoma de Buenos Aires

B1629ODT

Hospital Universitario Austral, Pilar

S2000AZH

Centro Médico Grupo Laser Visión, Rosario

C1015ABO

Organización Médica de Investigación, Ciudad Autónoma de BuenosAires

T3E-7M8

ACS Crichton Prof. Corp, Calgary

B3H 2Y9

Nova Scotia Health Authority, Department of Ophthalmology & Visual Sciences, Halifax

L4M455

Trimed Eye Center, Barrie

L4K225

Uptown Eye Specialists, Concord

K7K 6Z6

Galen Eye Centre, Kingston

L4W1W9

Ophthalmic Consultant Centres Inc, Mississauga

M4N3M5

Sunnybrook Research Institute, Toronto

J7J 2BJ

Institut De L'Oeil Des Laurentides, Boisbriand

J2C 2C4

Clinique d' ophtalmologie Dr Saurel, Drummondville

H1V 1GS

Bellevue Clinic, Montreal

J1G 2V4

GOGiunta Ophtalmologie, Sherbrooke

0000

Clinica de Oftalmologia Sandiego S.A., Medellín

06156

Ospedale Santa Maria Della Misericordia, Perugia

06011

Capital Eye Specialists, Wellington

0083

Pretoria Eye Institute, Arcadia

CB2 0QQ

Addenbrookes Hospital, Cambridge

PO6 3LY

Queen Alexandra Hospital, Cosham

EH3 9HA

Princess Alexandra Eye Pavilion, Edinburgh

NR31 6LA

James Paget University Hosp NHS Foundation Trust, Great Yarmouth

L7 8XP

St Paul's Eye Unit Royal Liverpool&Broadgreen, NHS Trust, Liverpool

L9 7AL

Aintree University Hospital NHS Foundation Trust, Liverpool

153-173

ICORG, London

SE1 7EH

In Patient Pharmacy, Ground Floor, Lambeth Wing St Thomas' Hospital, London

PE39GZ

Peterborough City Hospital Research and Development Department, Peterborough

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Allergan

INDUSTRY