Comparison of Bimatoprost Sustained Release (SR) to Selective Laser Trabeculoplasty (SLT) in Adults With Open-Angle Glaucoma or Ocular Hypertension

PHASE3CompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

August 27, 2015

Primary Completion Date

November 24, 2021

Study Completion Date

May 31, 2023

Conditions
Glaucoma, Open-AngleOcular Hypertension
Interventions
DRUG

Bimatoprost SR

Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is injected into the anterior chamber via the corneal limbus using the prefilled applicator.

DRUG

Sham Bimatoprost SR

Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.

PROCEDURE

Selective Laser Trabeculoplasty

"SLT is a laser procedure that targets the melanin, or pigment, in specific cells of the eye.~An ophthalmologist performed 360 degrees of SLT using a standardized method."

PROCEDURE

Sham Selective Laser Trabeculoplasty

Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state.

Trial Locations (95)

1050

Auckland Eye Hospital /ID# 235253, Remuera

1200

Asian Eye Institute /ID# 235092, Makati City

1209

Peregrine Eye and Laser Institute /ID# 236220, Makati City

1229

American Eye Center /ID# 235320, Makati City

1502

Cardinal Santos Medical Center /ID# 235325, San Juan City

2600

Rigshospitalet Glostrup /ID# 237709, Glostrup Municipality

3002

Eye Surgery Associates /ID# 235872, East Melbourne

3040

Essendon Eye Clinic /ID# 235433, Essendon

3058

Vision Eye Institute /ID# 236003, Melbourne

3150

Waverley Eye Clinic /ID# 234997, Glen Waverley

3220

Geelong Eye Clinic /ID# 236118, Geelong

4101

Queensland Eye Institute /ID# 236074, South Brisbane

6009

The Lions Eye Institute /ID# 236832, Nedlands

6011

Capital Eye Specialists /ID# 236111, Wellington

8013

Southern Eye Specialists /ID# 236081, Christchurch

13353

Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 235966, Berlin

16066

Scott and Christie and Associates /ID# 234594, Cranberry Township

18704

Eye Care Specialists /ID# 235129, Kingston

19107

Wills Eye Hospital /ID# 236487, Philadelphia

22046

Emerson Clinical Research Institute /ID# 235977, Falls Church

24502

Piedmont Eye Center /ID# 234533, Lynchburg

26501

West Virginia University Eye Institute /ID# 235174, Morgantown

27262

Duplicate_Cornerstone Eye Care /ID# 235047, High Point

27909

Albemarle Clinical Trials LLC /ID# 235144, Elizabeth City

29501

Carolinas Centers for Sight,PC /ID# 237017, Florence

31000

Chu Toulouse Purpan - Hopital Pierre Paul Riquet /ID# 235841, Toulouse

32204

Levenson Eye Associates Inc. /ID# 235021, Jacksonville

32209

University of Florida /ID# 236876, Jacksonville

33000

CHU Bordeaux - Hopital Pellegrin /ID# 237705, Bordeaux

33321

Dr. Andrew Gardner Logan, FL /ID# 236946, Tamarac

33484

Segal Drug Trials Inc. /ID# 235169, Delray Beach

33612

University of South Florida /ID# 237737, Tampa

34362

The Lady Davis Carmel Medical Center /ID# 236757, Haifa

34474

Ocala Eye PA /ID# 235431, Ocala

36301

Trinity Research Group /ID# 234598, Dothan

37411

Chattanooga Eye Institute /ID# 235250, Chattanooga

39120

Universitaetsklinikum Magdeburg /ID# 237284, Magdeburg

40212

Internationale Innovative Ophthalmochirurgie /ID# 235263, Düsseldorf

48026

Fraser Eye Center /ID# 235791, Fraser

49933

Chu Angers /Id# 237805, Angers

50300

Polyclinique de la Baie /ID# 235842, Avranches

58103

Bagan Strinden Vision /ID# 234898, Fargo

60612

University of Illinois at Chicago Illinois Eye and Ear Infirmary /ID# 234875, Chicago

63017

Midwest Vision Research Foundation at Pepose Vision Institute /ID# 235879, Chesterfield

66211

Sabates Eye Centers /ID# 234868, Leawood

67091

CHU Strasbourg - Hopital Civil /ID# 237837, Strasbourg

73112

Oklahoma Eye Surgeons /ID# 235848, Oklahoma City

77025

Houston Eye Associates /ID# 237883, Houston

77401

Cross Eye Center /ID# 236116, Bellaire

78215

San Antonio Eye Center /ID# 235632, San Antonio

78229

Eye associates /ID# 236501, San Antonio

78731

ATX Clinical Trials Inc. dba Keystone Research /ID# 235869, Austin

82000

Clinique Honore Cave - Pharmacie /ID# 235925, Montauban

85306

Arizona Advanced Eye Research Institute /ID# 234947, Glendale

85351

Walman Eye Center /ID# 236054, Sun City

86301

M&M Eye Institute /ID# 235391, Prescott

87109

Eye Associates of New Mexico /ID# 235115, Albuquerque

90505

Wolstan & Goldberg Eye Associates /ID# 235166, Torrance

91007

California Center for Clin Res /ID# 237412, Arcadia

91107

California Eye Specialists Medical Group Inc. /ID# 235999, Pasadena

91203

Speciality Eye Care Medical Group /ID# 236001, Glendale

91204

Lugene Eye Institute /ID# 237042, Glendale

92604

Lakeside Vision Center /ID# 234971, Irvine

92843

Orange County Ophthalmology /ID# 235995, Garden Grove

94115

Pacific Eye Associates /ID# 235326, San Francisco

443099

Samara State Medical University /ID# 236997, Samara

644024

Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 236041, Omsk

2210001

Galilee Medical Center /ID# 235742, Nahariya

3109601

Rambam Health Care Campus /ID# 237741, Haifa

4941492

Rabin Medical Center /ID# 237698, Petah Tikva

6423906

Tel Aviv Sourasky Medical Center /ID# 237211, Tel Aviv

85050-4265

Arizona Glaucoma Specialists /ID# 235066, Phoenix

94954-2387

North Bay Eye Associates Inc. /ID# 235429, Petaluma

33901-9311

Eye Associates of South West Florida /ID# 235424, Fort Myers

30260-4180

Clayton Eye Clinical Research, LLC /ID# 236678, Morrow

41017-3415

Cincinnati Eye Institute- Edgewood /ID# 236714, Edgewood

40206-1738

The Eye Care Institute /ID# 236690, Louisville

01867

Advanced Glaucoma Specialists /ID# 234799, Reading

07079-1855

Northern New Jersey Eye Institute PA /ID# 234944, South Orange

17601-2644

Family Eye Group P.C. /ID# 236114, Lancaster

77030-3411

Baylor College of Medicine - Baylor Medical Center /ID# 237148, Houston

78240-1502

Medical Center Ophthalmology Associates /ID# 235016, San Antonio

VIC3065

Melbourne Eye Specialists /ID# 234614, Fitzroy

H1V 1G5

Ophthalmology Clinic Bellevue /ID# 234631, Montreal

06000

CHU de Nice - Hospital Pasteur 2 /ID# 235844, Nice

10-424

Centrum Diagnostyki i Mikrochirurgii Oka - LENS dr n. med. Slawomir Zalewski /ID# 235929, Olsztyn

DE22 3NE

University Hospital of Derby and Burton NHS Foundation Trust /ID# 237129, Derby

DA14 6LT

Queen Mary's Hospital /ID# 234899, Greater London

SE1 9RT

Guys and St Thomas NHS Foundation Trust /ID# 236806, London

SM5 1AA

Epsom & St Helier University Hospital NHS Trust /ID# 236902, Carshalton

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust /ID# 238315, Cambridge

EH3 9HE

NHS Lothian /ID# 237450, Edinburgh

EC1V 2PD

Moorfields Eye Hospital NHS Foundation Trust /ID# 237708, London

W2 1NY

Imperial College Healthcare NHS Trust /ID# 234777, London

M13 9WL

Manchester University NHS Foundation Trust /ID# 237318, Manchester

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