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

Last updated: April 16, 2024
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Glaucoma

Williams Syndrome

Circulation Disorders

Treatment

Bimatoprost SR

Sham Selective Laser Trabeculoplasty

Sham Bimatoprost SR

Clinical Study ID

NCT02507687
192024-093
2015-002131-18
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of either open-angle glaucoma or ocular hypertension in each eye thatrequire IOP lowering treatment.
  • In the investigator's opinion, patient's IOP is not adequately managed with topicalmedication for reasons other than medication efficacy (eg, due to intolerance ornonadherence).
  • In the investigator's opinion, both eyes can be treated adequately with topicalprostamide, prostaglandin, or prostaglandin analog eye drops as the sole therapy ifmedication was taken as directed, or with SLT monotherapy.

Exclusion

Exclusion Criteria:

  • History of previous laser trabeculoplasty
  • History or evidence of complicated cataract surgery: eg, surgery resulting incomplicated lens placement (such as anterior chamber intraocular lens implant [IOL],sulcus IOL, aphakia, etc) or intraoperative complications (such as a posteriorcapsular tear [with or without vitreous loss], substantial iris trauma, etc) orhistory of phakic IOL insertion for refractive error correction
  • Intraocular surgery (including cataract surgery) and/or any ocular laser surgerywithin the 6 months prior to treatment
  • Previous use of commercially available Bimatoprost SR; concurrent enrollment inanother Allergan Bimatoprost SR study; or previous enrollment in which an implant wasreceived.

Study Design

Total Participants: 240
Treatment Group(s): 4
Primary Treatment: Bimatoprost SR
Phase: 3
Study Start date:
August 27, 2015
Estimated Completion Date:
May 31, 2023

Connect with a study center

  • Queensland Eye Institute /ID# 236074

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Bendigo Eye Clinic

    Bendigo, Victoria 3550
    Australia

    Site Not Available

  • Eye Surgery Associates /ID# 235872

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Melbourne Eye Specialists /ID# 234614

    Fitzroy, Victoria VIC3065
    Australia

    Site Not Available

  • Waverley Eye Clinic /ID# 234997

    Glen Waverley, Victoria 3150
    Australia

    Site Not Available

  • The University of Western Australia - Lions Eye Institute

    Crawley, Western Australia 6009
    Australia

    Site Not Available

  • The Lions Eye Institute /ID# 236832

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Essendon Eye Clinic /ID# 235433

    Essendon, 3040
    Australia

    Site Not Available

  • Geelong Eye Clinic /ID# 236118

    Geelong, 3220
    Australia

    Site Not Available

  • Vision Eye Institute /ID# 236003

    Melbourne, 3058
    Australia

    Site Not Available

  • Waverley Eye Clinic

    Victoria, 3150
    Australia

    Site Not Available

  • Nova Scotia Health Authority

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • St. Joseph's Hamilton Healthcare Hospital

    Hamilton, Ontario L86 5E4
    Canada

    Site Not Available

  • Institut de loeil des Laurentides

    Boisbriand, Quebec 76546
    Canada

    Site Not Available

  • Ophthalmology Clinic Bellevue /ID# 234631

    Montreal, Quebec H1V 1G5
    Canada

    Site Not Available

  • Ophthalmic Consultant Centres

    Mississauga, L4W1W9
    Canada

    Site Not Available

  • St. Joseph's Hamilton Healthcare Hospital

    Ontario, L86 5E4
    Canada

    Site Not Available

  • Rigshospitalet Glostrup /ID# 237709

    Glostrup, Hovedstaden 2600
    Denmark

    Site Not Available

  • SA IVKH

    Kohtla-Jarve, 31025
    Estonia

    Site Not Available

  • O Dr Kai Noor Silmakabinet

    Tallinn, 11412
    Estonia

    Site Not Available

  • Eye Clinic of Tartu University Hospital

    Tartu, 51014
    Estonia

    Site Not Available

  • Chu Angers /Id# 237805

    Angers, 49933
    France

    Site Not Available

  • CHU Angers - Service d'Ophtalmologie

    Angers Cedex 9, 49933
    France

    Site Not Available

  • Polyclinique de la Baie /ID# 235842

    Avranches, 50300
    France

    Site Not Available

  • CHU Bordeaux - Hopital Pellegrin /ID# 237705

    Bordeaux, 33000
    France

    Site Not Available

  • Clinique Honore Cave - Pharmacie /ID# 235925

    Montauban, 82000
    France

    Site Not Available

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

    Nice, 06000
    France

    Site Not Available

  • Nouvel Hôpital Civil Hôpital civil

    Strasbourg, 67091
    France

    Site Not Available

  • CHU Strasbourg - Hopital Civil /ID# 237837

    Strasbourg cedex, 67091
    France

    Site Not Available

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

    Toulouse, 31000
    France

    Site Not Available

  • CHU Toulouse Purpan - Hopital Pierre Paul Riquet

    Toulouse cedex 9, 31000
    France

    Site Not Available

  • Internationale Innovative Ophthalmochirurgie /ID# 235263

    Dusseldorf, Nordrhein-Westfalen 40212
    Germany

    Site Not Available

  • Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 235966

    Berlin, 13353
    Germany

    Site Not Available

  • Internationale Innovative Ophthalmochirurgie

    Düsseldorf, 40212
    Germany

    Site Not Available

  • Klinik und Poliklinik fuer Augenheilkunde

    Greifswald, 17475
    Germany

    Site Not Available

  • UNIVERSITÄTSKLINIKUM - Schleswig-Holstein

    Grisanti, 23538
    Germany

    Site Not Available

  • Universitaetsklinikum Magdeburg /ID# 237284

    Magdeburg, 39120
    Germany

    Site Not Available

  • Universitaetsaugenklinik

    Margdeburg, 39120
    Germany

    Site Not Available

  • Universitaetsaugenklinik LMU

    Munchen, 80336
    Germany

    Site Not Available

  • Universitaets-Augenklinik

    Munster, 48149
    Germany

    Site Not Available

  • Universitat Augenklinik

    Ulm, 89075
    Germany

    Site Not Available

  • Tel-Aviv Medical Centre

    Givatayim, Tel Aviv 64239
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center /ID# 237211

    Tel Aviv-Yafo, Tel-Aviv 6423906
    Israel

    Site Not Available

  • Rambam Health Care Campus /ID# 237741

    Haifa, 3109601
    Israel

    Site Not Available

  • The Lady Davis Carmel Medical Center /ID# 236757

    Haifa, 34362
    Israel

    Site Not Available

  • Galilee Medical Center /ID# 235742

    Naharia, 2210001
    Israel

    Site Not Available

  • Galilee Medical Center /ID# 235742

    Nahariya, 2210001
    Israel

    Site Not Available

  • Galilee Medical Center

    Nahariyya, 2210001
    Israel

    Site Not Available

  • The Rabin Medical Center

    Petach Tiqva, 49100
    Israel

    Site Not Available

  • Rabin Medical Center /ID# 237698

    Petakh Tikva, 4941492
    Israel

    Site Not Available

  • Chaim Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Tel-Aviv Medical Centre

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Auckland Eye Hospital /ID# 235253

    Remuera, Auckland 1050
    New Zealand

    Site Not Available

  • Southern Eye Specialists /ID# 236081

    Christchurch, Canterbury 8013
    New Zealand

    Site Not Available

  • Capital Eye Specialists /ID# 236111

    Wellington, 6011
    New Zealand

    Site Not Available

  • American Eye Center /ID# 235320

    Makati City, 1229
    Philippines

    Site Not Available

  • Asian Eye Institute /ID# 235092

    Makati City, 1200
    Philippines

    Site Not Available

  • Peregrine Eye and Laser Institute /ID# 236220

    Makati City, 1209
    Philippines

    Site Not Available

  • Cardinal Santos Medical Center

    San Juan, 1502
    Philippines

    Site Not Available

  • Cardinal Santos Medical Center /ID# 235325

    San Juan City, 1502
    Philippines

    Site Not Available

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

    Olsztyn, 10-424
    Poland

    Site Not Available

  • Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 235929

    Olsztyn, 10-424
    Poland

    Site Not Available

  • S..Fyodorov Eye Microsurgery Federal State Institution

    Novosibirsk, 630071
    Russian Federation

    Site Not Available

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

    Omsk, 644024
    Russian Federation

    Site Not Available

  • Samara State Medical University /ID# 236997

    Samara, 443099
    Russian Federation

    Site Not Available

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

    Derby, Derbyshire DE22 3NE
    United Kingdom

    Site Not Available

  • Queen Mary's Hospital /ID# 234899

    Greater London, Kent DA14 6LT
    United Kingdom

    Site Not Available

  • Guys and St Thomas NHS Foundation Trust /ID# 236806

    London, London, City Of SE1 9RT
    United Kingdom

    Site Not Available

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

    Carshalton, Surrey SM5 1AA
    United Kingdom

    Site Not Available

  • Queen Elisabeth Hospital Birmingham

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • Sussex Eye Hospital

    Brighton, BN2 5BF
    United Kingdom

    Site Not Available

  • Bristol Eye Hospital

    Bristol, BS1 2LX
    United Kingdom

    Site Not Available

  • Cambridge University Hospitals NHS Foundation Trust /ID# 238315

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • NHS Lothian /ID# 237450

    Edinburgh, EH3 9HE
    United Kingdom

    Site Not Available

  • Imperial College Healthcare NHS Trust /ID# 234777

    London, W2 1NY
    United Kingdom

    Site Not Available

  • Moorfields Eye Hospital NHS Foundation Trust /ID# 237708

    London, EC1V 2PD
    United Kingdom

    Site Not Available

  • Manchester University NHS Foundation Trust /ID# 237318

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Queen Alexandra Hospital

    Portsmouth, PO6 3LY
    United Kingdom

    Site Not Available

  • Salisbury NHS foundation trust

    Salisbury, SP2 8BJ
    United Kingdom

    Site Not Available

  • Queen Mary's Hospital Sidcup

    Sidcup, DA14 6LT
    United Kingdom

    Site Not Available

  • Epsom & St Helier University Hospitals NHS Trust

    Sutton, SM5 1AA
    United Kingdom

    Site Not Available

  • York teaching Hospital NHS Foundation Trust

    York, YO31 8HE
    United Kingdom

    Site Not Available

  • Trinity Research Group /ID# 234598

    Dothan, Alabama 36301
    United States

    Site Not Available

  • Arizona Advanced Eye Research Institute /ID# 234947

    Glendale, Arizona 85306
    United States

    Site Not Available

  • Arizona Glaucoma Specialists /ID# 235066

    Phoenix, Arizona 85050-4265
    United States

    Site Not Available

  • M&M Eye Institute /ID# 235391

    Prescott, Arizona 86301
    United States

    Site Not Available

  • Walman Eye Center /ID# 236054

    Sun City, Arizona 85351
    United States

    Site Not Available

  • California Center for Clin Res /ID# 237412

    Arcadia, California 91007
    United States

    Site Not Available

  • Orange County Ophthalmology /ID# 235995

    Garden Grove, California 92843
    United States

    Site Not Available

  • Lugene Eye Institute /ID# 237042

    Glendale, California 91204
    United States

    Site Not Available

  • Speciality Eye Care Medical Group /ID# 236001

    Glendale, California 91203
    United States

    Site Not Available

  • Lakeside Vision Center /ID# 234971

    Irvine, California 92604
    United States

    Site Not Available

  • California Eye Specialists Medical Group Inc. /ID# 235999

    Pasadena, California 91107
    United States

    Site Not Available

  • North Bay Eye Associates Inc. /ID# 235429

    Petaluma, California 94954-2387
    United States

    Site Not Available

  • Pacific Eye Associates /ID# 235326

    San Francisco, California 94115
    United States

    Site Not Available

  • Wolstan & Goldberg Eye Associates /ID# 235166

    Torrance, California 90505
    United States

    Site Not Available

  • WCCT Global

    Tustin, California 92705
    United States

    Site Not Available

  • Segal Drug Trials Inc. /ID# 235169

    Delray Beach, Florida 33484
    United States

    Site Not Available

  • Eye Associates of South West Florida

    Fort Meyers, Florida 33901
    United States

    Site Not Available

  • Eye Associates of South West Florida /ID# 235424

    Fort Myers, Florida 33901-9311
    United States

    Site Not Available

  • Levenson Eye Associates Inc. /ID# 235021

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • University of Florida /ID# 236876

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Ocala Eye PA /ID# 235431

    Ocala, Florida 34474
    United States

    Site Not Available

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

    Tamarac, Florida 33321
    United States

    Site Not Available

  • University of South Florida /ID# 237737

    Tampa, Florida 33612
    United States

    Site Not Available

  • Accusite Surgical Services

    Duluth, Georgia 30096
    United States

    Site Not Available

  • Clayton Eye Clinical Research, LLC /ID# 236678

    Morrow, Georgia 30260-4180
    United States

    Site Not Available

  • Intermountain Eye Centers

    Boise, Idaho 83713
    United States

    Site Not Available

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

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Sabates Eye Centers /ID# 234868

    Leawood, Kansas 66211
    United States

    Site Not Available

  • Stiles Eyecare and Glaucoma Institute

    Overland Park, Kansas 66213
    United States

    Site Not Available

  • Cincinnati Eye Institute- Edgewood /ID# 236714

    Edgewood, Kentucky 41017-3415
    United States

    Site Not Available

  • UK HealthCare Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • The Eye Care Institute /ID# 236690

    Louisville, Kentucky 40206-1738
    United States

    Site Not Available

  • Advanced Glaucoma Specialists /ID# 234799

    Reading, Massachusetts 01867
    United States

    Site Not Available

  • Kresge Eye Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Fraser Eye Center /ID# 235791

    Fraser, Michigan 48026
    United States

    Site Not Available

  • Huron Ophthalmology P.C.

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Midwest Vision Research Foundation at Pepose Vision Institute /ID# 235879

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Wellish Vision Institute /ID# 236064

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Northern New Jersey Eye Institute PA /ID# 234944

    South Orange, New Jersey 07079-1855
    United States

    Site Not Available

  • Eye Associates of New Mexico /ID# 235115

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Albemarle Clinical Trials LLC /ID# 235144

    Elizabeth City, North Carolina 27909
    United States

    Site Not Available

  • Duplicate_Cornerstone Eye Care /ID# 235047

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Bagan Strinden Vision /ID# 234898

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Cincinnati Eye Institute

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Oklahoma Eye Surgeons /ID# 235848

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Scott and Christie and Associates /ID# 234594

    Cranberry Township, Pennsylvania 16066
    United States

    Site Not Available

  • Eye Care Specialists /ID# 235129

    Kingston, Pennsylvania 18704
    United States

    Site Not Available

  • Family Eye Group P.C. /ID# 236114

    Lancaster, Pennsylvania 17601-2644
    United States

    Site Not Available

  • Wills Eye Hospital /ID# 236487

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Carolinas Centers for Sight,PC /ID# 237017

    Florence, South Carolina 29501
    United States

    Site Not Available

  • Chattanooga Eye Institute /ID# 235250

    Chattanooga, Tennessee 37411
    United States

    Site Not Available

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

    Austin, Texas 78731
    United States

    Site Not Available

  • Cross Eye Center /ID# 236116

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Baylor College of Medicine - Baylor Medical Center /ID# 237148

    Houston, Texas 77030-3411
    United States

    Site Not Available

  • Houston Eye Associates /ID# 237883

    Houston, Texas 77025
    United States

    Site Not Available

  • Eye associates /ID# 236501

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Medical Center Ophthalmology Associates /ID# 235016

    San Antonio, Texas 78240-1502
    United States

    Site Not Available

  • San Antonio Eye Center /ID# 235632

    San Antonio, Texas 78215
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Emerson Clinical Research Institute /ID# 235977

    Falls Church, Virginia 22046
    United States

    Site Not Available

  • Piedmont Eye Center /ID# 234533

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • West Virginia University Eye Institute /ID# 235174

    Morgantown, West Virginia 26501
    United States

    Site Not Available

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