Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension (TRITON)

August 18, 2025 updated by: AbbVie

A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

This study evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of as needed administrations of Bimatoprost sustained release (SR) in participants with open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

515

Phase

  • Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1181
        • Hospital Italiano /ID# 235851
      • Ciudad Autonoma Buenos Aires, Argentina, 1033
        • Centro Privado de Ojos /ID# 241283
      • Mendoza, Argentina, 1019
        • Oftar Mendoza /ID# 240535
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, 1122
        • Consultorio Oftalmologico Dr. Fabian Lerner /ID# 235855
      • Pilar, Buenos Aires, Argentina, 1629
        • Hospital Universitario Austral /ID# 237727
    • Ciudad Autonoma De Buenos Aires
      • Ciudad de Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina, 1116
        • Centro oftalmologico Dr Charles /ID# 235881
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Oftalmología Global /ID# 239187
  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Eye Surgery Associates /ID# 235873
  • Bulgaria
      • Burgas, Bulgaria, 8008
        • Medical Center Oxycom Burgas /ID# 235580
      • Plovdiv, Bulgaria, 4002
        • UMHAT Sveti Georgi /ID# 237027
      • Sliven, Bulgaria, 8800
        • MHAT Hadzhi Dimitar /ID# 238248
      • Smolyan, Bulgaria, 4700
        • MHAT Dr. Bratan Shukerov /ID# 235498
      • Sofia, Bulgaria, 1303
        • Medical center for eye healt Focus Ltd /ID# 235575
      • Sofia, Bulgaria, 1309
        • Pentagram Eye Hospital /ID# 235813
      • Sofia, Bulgaria, 1408
        • Specialized Hospital for Active Treatment in Ocular Diseases "Zrenie" /ID# 235500
      • Sofia, Bulgaria, 1618
        • St. Sofia Hospital /ID# 235525
      • Stara Zagora, Bulgaria, 6000
        • Medical Center -Verea /ID# 235494
      • Stara Zagora, Bulgaria, 6000
        • Medical center Orfey /ID# 237344
      • Stara Zagora, Bulgaria, 6004
        • MHAT Trakia /ID# 238137
      • Varna, Bulgaria, 9002
        • Specialized Ophthalmological Hospital for Active Treatment - Varna /ID# 235962
    • Sofia
      • Sofiya, Sofia, Bulgaria, 1407
        • Multiprofile Hospital for Active Treatment "Lozenetz" /ID# 244053
      • Sofiya, Sofia, Bulgaria, 1431
        • Diagnostic Consultative Center Aleksandrovska /ID# 238105
  • Czechia
      • Pardubice, Czechia, 530 02
        • Ocni klinika Pardubice /ID# 235944
      • Praha, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady /ID# 234323
    • Praha 17
      • Praha, Praha 17, Czechia, 128 00
        • Všeobecná Fakultní Nemocnice v Praze /ID# 234422
  • Denmark
    • Hovedstaden
      • Glostrup, Hovedstaden, Denmark, 2600
        • Rigshospitalet Glostrup /ID# 235743
  • Germany
      • Dresden, Germany, 01067
        • Klinikum Dresden Friedrichstadt /ID# 235308
      • Hamburg, Germany, 22417
        • Asklepios Kinik Nord - Heidberg Augenklinik /ID# 235955
      • Muenster, Germany, 48145
        • St. Franziskus-Hospital /ID# 237714
      • Neubrandenburg, Germany, 17036
        • Dietrich-Bonhoeffer-Klinikum /ID# 235262
      • Starnberg, Germany, 82319
        • Augenzentrum Dr Hamacher /ID# 235537
    • Baden-Wuerttemberg
      • Freiburg im Breisgau, Baden-Wuerttemberg, Germany, 79106
        • Universitatsklinikum Freiburg /ID# 238048
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18057
        • Universitaetsmedizin Rostock /ID# 237263
    • Niedersachsen
      • Goettingen, Niedersachsen, Germany, 37075
        • Universitaetsmedizin Goettingen /ID# 237377
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 237069
  • Hungary
      • Budapest, Hungary, 1133
        • Budapest Retina Intezet /ID# 235950
      • Budapest, Hungary, 1204
        • Jahn Ferenc Del-pesti Korhaz es Rendelointezet /ID# 237111
    • Heves
      • Gyongyos, Heves, Hungary, 3200
        • Gyongyosi Bugat Pal Korhaz /ID# 238144
    • Vas
      • Szombathely, Vas, Hungary, 9700
        • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 237383
  • Ireland
      • Dublin, Ireland, 2
        • Royal Victoria Eye and Ear Hospital /ID# 235546
      • Waterford, Ireland, X91 DH9W
        • Institute of Eye Surgery /ID# 235547
  • Italy
      • Catania, Italy, 95123
        • Duplicate_Eye Clinic University of Catania /ID# 235573
      • Chieti, Italy, 66100
        • Duplicate_Ospedale Ss. Annunziata /ID# 236587
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo /ID# 236909
      • Perugia, Italy, 06156
        • University of Perugia /ID# 235811
      • Rome, Italy, 00184
        • Fondazione Bietti - Ospedale Britannico /ID# 235495
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • University of Catanzaro /ID# 238066
    • Latina
      • Terracina, Latina, Italy, 04019
        • Sapienza University of Rome - Polo Pontino /ID# 237451
  • New Zealand
      • Wellington, New Zealand, 6011
        • Capital Eye Specialists /ID# 236112
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8013
        • Southern Eye Specialists /ID# 236080
  • Poland
      • Katowice, Poland, 40-594
        • Gabinet Okulistyczny Edward Wylegala /ID# 235946
    • Lodzkie
      • Lodz, Lodzkie, Poland, 91-485
        • Medical Center Julianow /ID# 235961
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 04-349
        • Wojskowy Instytut Medyczny /ID# 237031
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-809
        • Optimum Profesorskie Centrum Okulistyki SP.z.o.o. /ID# 237076
    • Warminsko-mazurskie
      • Olsztyn, Warminsko-mazurskie, Poland, 10-424
        • Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 235928
  • Russian Federation
    • Novosibirskaya Oblast
      • Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630071
        • S. Fyodorov Eye Microsurgery Federal State Institution /ID# 235984
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0083
        • Pretoria Eye Institute - Private Practice /ID# 235658
    • Western Cape
      • Somerset West, Western Cape, South Africa, 7130
        • Somerset Eye Specialist Medical & Surgical Centre /ID# 235540
  • Sweden
    • Vasterbottens Lan
      • Umea, Vasterbottens Lan, Sweden, 581 85
        • Norrlands University hospital /ID# 237553
  • United Kingdom
      • Colchester, United Kingdom, CO4 5JL
        • East Suffolk and North Essex NHS Foundation Trust /ID# 234657
      • Crewe, United Kingdom, CW1 4QJ
        • Mid-Cheshire Hospitals NHS Trust /ID# 235418
      • Liverpool, United Kingdom, L7 8XP
        • Liverpool University Hospitals NHS Foundation Trust /ID# 237095
      • Liverpool, United Kingdom, L7 8XP
        • Liverpool University Hospitals NHS Foundation Trust /ID# 237321
      • London, United Kingdom, NW10 7NS
        • Central Middlesex Hospital /ID# 236216
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Addenbrookes Hospital /ID# 238255
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 7ET
        • Mid Essex Hospitals NHS Trust /ID# 237776
      • Harlow, Essex, United Kingdom, CM20 1QX
        • The Princess Alexandra NHS Trust /ID# 234433
    • Greater London
      • London, Greater London, United Kingdom, SE5 9RS
        • Kings College Hospital NHS Foundation Trust /ID# 237275
    • North Yorkshire
      • York, North Yorkshire, United Kingdom, YO31 8HE
        • York Hospital /ID# 237683
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust /ID# 237282
  • United States
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Horizon Eye Specialists & Lasik Centers /ID# 235240
    • California
      • Huntington Beach, California, United States, 92647
        • Atlantis Eye Care /ID# 235530
      • Irvine, California, United States, 92604
        • Lakeside Vision Center /ID# 234970
      • Los Angeles, California, United States, 90041-1718
        • Global Research Foundation /ID# 237350
      • Newport Beach, California, United States, 92663-3637
        • The Eye Research Foundation /ID# 234521
      • Palo Alto, California, United States, 94303
        • Byers Eye Institute Stanford /ID# 235544
      • Pasadena, California, United States, 91107
        • Foothill Eye Institute /ID# 235640
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Connecticut Eye Consultants P.C. /ID# 234981
    • Florida
      • Deerfield Beach, Florida, United States, 33064-1342
        • Advanced Research, LLC /ID# 236045
      • Delray Beach, Florida, United States, 33484
        • Segal Drug Trials, Inc /ID# 235784
      • Tampa, Florida, United States, 33603
        • International Research Center /ID# 238050
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Thomas Eye Group PC /ID# 235737
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University - Glick Eye Institute /ID# 235886
      • Indianapolis, Indiana, United States, 46290
        • Retina Partners Midwest, PC /ID# 237876
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine /ID# 237632
    • Massachusetts
      • Boston, Massachusetts, United States, 02129
        • Ophthalmic Consultants of Boston /ID# 236534
      • Winchester, Massachusetts, United States, 01890
        • Clinical Eye Research of Boston LLC /ID# 234966
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • University of Michigan, Kellogg Eye Center /ID# 236496
      • Fraser, Michigan, United States, 48026
        • Fraser Eye Center /ID# 235790
    • Missouri
      • Kansas City, Missouri, United States, 64034
        • Silverstein Eye Centers /ID# 237881
      • Kansas City, Missouri, United States, 64154
        • Moyes Eye Centers /ID# 234989
    • New York
      • Poughkeepsie, New York, United States, 12603-2455
        • Alterman Modi & Wolter /ID# 235248
    • Ohio
      • Columbus, Ohio, United States, 43210-1257
        • The Ohio State University /ID# 236790
      • Marysville, Ohio, United States, 43040
        • AMA Eyes Research Institute /ID# 235542
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Dean McGee Eye Institute /ID# 236823
      • Oklahoma City, Oklahoma, United States, 73112
        • Oklahoma Eye Surgeons /ID# 235849
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Drs Fine Hoffman & Sims LLC /ID# 235918
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Ophthalmic Partners, PC /ID# 235741
      • Cranberry Township, Pennsylvania, United States, 16066
        • Scott and Christie and Associates /ID# 234593
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute /ID# 235075
      • Sioux Falls, South Dakota, United States, 57108
        • Vance Thompson Vision /ID# 235072
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Eye Specialty Group /ID# 235721
      • Nashville, Tennessee, United States, 37232-0011
        • Vanderbilt University Medical Center /ID# 237177
      • Smyrna, Tennessee, United States, 37167
        • Advancing Vision Research /ID# 236681
    • Texas
      • Austin, Texas, United States, 78731
        • ATX Clinical Trials Inc. dba Keystone Research /ID# 235868
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Associates - Keystone Research /ID# 235787
    • Utah
      • Saint George, Utah, United States, 84790
        • Southern Utah Medical Research /ID# 235602
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Piedmont Eye Center /ID# 234534

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular pressure-lowering treatment.

Exclusion Criteria:

  • Concurrent or anticipated enrollment in another investigational drug or device study or participation in such a study within 2 months prior to enrolling in this study.
  • Previous administration with Bimatoprost SR in the study eye.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bimatoprost SR - Dose A

Study Eye: Participants will receive 1 - 2 Cycles of Bimatoprost SR administrations of Dose A

Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.
Drug: Bimatoprost (SR)

Study Eye: Cycles 1 - 3 administrations through the PRN treatment period.

Fellow Eye: Standard of care or Bimatoprost SR.
Experimental: Bimatoprost SR - Dose B

Study Eye: Participants received 1 - 3 Cycles of Bimatoprost SR administrations of Dose B

Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.
Drug: Bimatoprost (SR)

Study Eye: Cycles 1 - 3 administrations through the PRN treatment period.

Fellow Eye: Standard of care or Bimatoprost SR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retreatment or rescue administered for IOP
Time Frame: Up to 48 months
Treatment modality determined by investigator.
Up to 48 months
Number of patients experiencing a treatment emergent adverse event
Time Frame: Baseline up to 48 months
The number of patients who experienced one or more TEAE during the 48 month treatment period.
Baseline up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2019

Primary Completion (Actual)

August 8, 2025

Study Completion (Actual)

August 8, 2025

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 22, 2019

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1698-301-007
  • 2018-002574-52 (EudraCT Number)
  • 2022-502380-37-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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