AzTrials
AzTrials

Open-Angle GlaucomaPhase 3TRITONNCT03850782

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

A Phase 3 study testing Bimatoprost (SR) in people with Open-Angle Glaucoma and Ocular Hypertension, run by AbbVie at 108 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Open-Angle Glaucoma, Ocular Hypertension
What is being tested?
Bimatoprost (SR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
515 participants
Where
108 sitesin 16 countries
Study dates
28 Feb 2019to 8 Aug 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

108 sites in 16 countries.

108 sites in 16 countries

United States38 sites

  • University of Michigan, Kellogg Eye Center /ID# 236496

    Ann Arbor, Michigan, 48105

  • ATX Clinical Trials Inc. dba Keystone Research /ID# 235868

    Austin, Texas, 78731

  • Ophthalmic Partners, PC /ID# 235741

    Bala-Cynwyd, Pennsylvania, 19004

  • Ophthalmic Consultants of Boston /ID# 236534

    Boston, Massachusetts, 02129

  • The Ohio State University /ID# 236790

    Columbus, Ohio, 43210-1257

  • Scott and Christie and Associates /ID# 234593

    Cranberry Township, Pennsylvania, 16066

  • Connecticut Eye Consultants P.C. /ID# 234981

    Danbury, Connecticut, 06810

  • Advanced Research, LLC /ID# 236045

    Deerfield Beach, Florida, 33064-1342

  • Segal Drug Trials, Inc /ID# 235784

    Delray Beach, Florida, 33484

  • Drs Fine Hoffman & Sims LLC /ID# 235918

    Eugene, Oregon, 97401

  • Fraser Eye Center /ID# 235790

    Fraser, Michigan, 48026

  • Atlantis Eye Care /ID# 235530

    Huntington Beach, California, 92647

  • Indiana University - Glick Eye Institute /ID# 235886

    Indianapolis, Indiana, 46202

  • Retina Partners Midwest, PC /ID# 237876

    Indianapolis, Indiana, 46290

  • Lakeside Vision Center /ID# 234970

    Irvine, California, 92604

  • Silverstein Eye Centers /ID# 237881

    Kansas City, Missouri, 64034

  • Moyes Eye Centers /ID# 234989

    Kansas City, Missouri, 64154

  • Global Research Foundation /ID# 237350

    Los Angeles, California, 90041-1718

  • Piedmont Eye Center /ID# 234534

    Lynchburg, Virginia, 24502

  • AMA Eyes Research Institute /ID# 235542

    Marysville, Ohio, 43040

  • Eye Specialty Group /ID# 235721

    Memphis, Tennessee, 38120

  • Vanderbilt University Medical Center /ID# 237177

    Nashville, Tennessee, 37232-0011

  • Tulane University School of Medicine /ID# 237632

    New Orleans, Louisiana, 70112

  • The Eye Research Foundation /ID# 234521

    Newport Beach, California, 92663-3637

  • Dean McGee Eye Institute /ID# 236823

    Oklahoma City, Oklahoma, 73104

  • Oklahoma Eye Surgeons /ID# 235849

    Oklahoma City, Oklahoma, 73112

  • Byers Eye Institute Stanford /ID# 235544

    Palo Alto, California, 94303

  • Foothill Eye Institute /ID# 235640

    Pasadena, California, 91107

  • Alterman Modi & Wolter /ID# 235248

    Poughkeepsie, New York, 12603-2455

  • Black Hills Regional Eye Institute /ID# 235075

    Rapid City, South Dakota, 57701

  • Medical Center Ophthalmology Associates - Keystone Research /ID# 235787

    San Antonio, Texas, 78240

  • Thomas Eye Group PC /ID# 235737

    Sandy Springs, Georgia, 30328

  • Vance Thompson Vision /ID# 235072

    Sioux Falls, South Dakota, 57108

  • Advancing Vision Research /ID# 236681

    Smyrna, Tennessee, 37167

  • Southern Utah Medical Research /ID# 235602

    St. George, Utah, 84790

  • Horizon Eye Specialists & Lasik Centers /ID# 235240

    Sun City, Arizona, 85351

  • International Research Center /ID# 238050

    Tampa, Florida, 33603

  • Clinical Eye Research of Boston LLC /ID# 234966

    Winchester, Massachusetts, 01890

Other trials in United States

Bulgaria14 sites

  • Medical Center Oxycom Burgas /ID# 235580

    Burgas, 8008

  • UMHAT Sveti Georgi /ID# 237027

    Plovdiv, 4002

  • MHAT Hadzhi Dimitar /ID# 238248

    Sliven, 8800

  • MHAT Dr. Bratan Shukerov /ID# 235498

    Smolyan, 4700

  • Medical center for eye healt Focus Ltd /ID# 235575

    Sofia, 1303

  • Pentagram Eye Hospital /ID# 235813

    Sofia, 1309

  • Specialized Hospital for Active Treatment in Ocular Diseases "Zrenie" /ID# 235500

    Sofia, 1408

  • St. Sofia Hospital /ID# 235525

    Sofia, 1618

  • Multiprofile Hospital for Active Treatment "Lozenetz" /ID# 244053

    Sofiya, Sofia, 1407

  • Diagnostic Consultative Center Aleksandrovska /ID# 238105

    Sofiya, Sofia, 1431

  • Medical Center -Verea /ID# 235494

    Stara Zagora, 6000

  • Medical center Orfey /ID# 237344

    Stara Zagora, 6000

  • MHAT Trakia /ID# 238137

    Stara Zagora, 6004

  • Specialized Ophthalmological Hospital for Active Treatment - Varna /ID# 235962

    Varna, 9002

Other trials in Bulgaria

United Kingdom11 sites

  • Addenbrookes Hospital /ID# 238255

    Cambridge, Cambridgeshire, CB2 2QQ

  • Mid Essex Hospitals NHS Trust /ID# 237776

    Chelmsford, Essex, CM1 7ET

  • East Suffolk and North Essex NHS Foundation Trust /ID# 234657

    Colchester, CO4 5JL

  • Mid-Cheshire Hospitals NHS Trust /ID# 235418

    Crewe, CW1 4QJ

  • The Princess Alexandra NHS Trust /ID# 234433

    Harlow, Essex, CM20 1QX

  • Liverpool University Hospitals NHS Foundation Trust /ID# 237095

    Liverpool, L7 8XP

  • Liverpool University Hospitals NHS Foundation Trust /ID# 237321

    Liverpool, L7 8XP

  • Kings College Hospital NHS Foundation Trust /ID# 237275

    London, Greater London, SE5 9RS

  • Central Middlesex Hospital /ID# 236216

    London, NW10 7NS

  • Oxford University Hospitals NHS Foundation Trust /ID# 237282

    Oxford, Oxfordshire, OX3 9DU

  • York Hospital /ID# 237683

    York, North Yorkshire, YO31 8HE

Other trials in United Kingdom

Germany9 sites

  • Klinikum Dresden Friedrichstadt /ID# 235308

    Dresden, 01067

  • Universitatsklinikum Freiburg /ID# 238048

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universitaetsmedizin Goettingen /ID# 237377

    Göttingen, Lower Saxony, 37075

  • Asklepios Kinik Nord - Heidberg Augenklinik /ID# 235955

    Hamburg, 22417

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 237069

    Kiel, Schleswig-Holstein, 24105

  • St. Franziskus-Hospital /ID# 237714

    Münster, 48145

  • Dietrich-Bonhoeffer-Klinikum /ID# 235262

    Neubrandenburg, 17036

  • Universitaetsmedizin Rostock /ID# 237263

    Rostock, Mecklenburg-Vorpommern, 18057

  • Augenzentrum Dr Hamacher /ID# 235537

    Starnberg, 82319

Other trials in Germany

Argentina7 sites

  • Hospital Italiano /ID# 235851

    Buenos Aires, 1181

  • Consultorio Oftalmologico Dr. Fabian Lerner /ID# 235855

    CABA, Buenos Aires, 1122

  • Centro Privado de Ojos /ID# 241283

    Ciudad Autonoma Buenos Aires, 1033

  • Centro oftalmologico Dr Charles /ID# 235881

    Ciudad de Buenos Aires, Buenos Aires F.D., 1116

  • Oftar Mendoza /ID# 240535

    Mendoza, 1019

  • Hospital Universitario Austral /ID# 237727

    Pilar, Buenos Aires, 1629

  • Oftalmología Global /ID# 239187

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Italy7 sites

  • Duplicate_Eye Clinic University of Catania /ID# 235573

    Catania, 95123

  • University of Catanzaro /ID# 238066

    Catanzaro, Calabria, 88100

  • Duplicate_Ospedale Ss. Annunziata /ID# 236587

    Chieti, 66100

  • Fondazione IRCCS Policlinico San Matteo /ID# 236909

    Pavia, 27100

  • University of Perugia /ID# 235811

    Perugia, 06156

  • Fondazione Bietti - Ospedale Britannico /ID# 235495

    Rome, 00184

  • Sapienza University of Rome - Polo Pontino /ID# 237451

    Terracina, Latina, 04019

Other trials in Italy

Poland5 sites

  • Optimum Profesorskie Centrum Okulistyki SP.z.o.o. /ID# 237076

    Gdansk, Pomeranian Voivodeship, 80-809

  • Gabinet Okulistyczny Edward Wylegala /ID# 235946

    Katowice, 40-594

  • Medical Center Julianow /ID# 235961

    Lodz, Łódź Voivodeship, 91-485

  • Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 235928

    Olsztyn, Warmian-Masurian Voivodeship, 10-424

  • Wojskowy Instytut Medyczny /ID# 237031

    Warsaw, Masovian Voivodeship, 04-349

Other trials in Poland

Hungary4 sites

  • Budapest Retina Intezet /ID# 235950

    Budapest, 1133

  • Jahn Ferenc Del-pesti Korhaz es Rendelointezet /ID# 237111

    Budapest, 1204

  • Gyongyosi Bugat Pal Korhaz /ID# 238144

    Gyöngyös, Heves County, 3200

  • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 237383

    Szombathely, Vas County, 9700

Other trials in Hungary

Czechia3 sites

  • Ocni klinika Pardubice /ID# 235944

    Pardubice, 530 02

  • Všeobecná Fakultní Nemocnice v Praze /ID# 234422

    Prague, Praha 17, 128 00

  • Fakultni nemocnice Kralovske Vinohrady /ID# 234323

    Prague, 100 34

Other trials in Czechia

Ireland2 sites

  • Royal Victoria Eye and Ear Hospital /ID# 235546

    Dublin, 2

  • Institute of Eye Surgery /ID# 235547

    Waterford, X91 DH9W

Other trials in Ireland

New Zealand2 sites

  • Southern Eye Specialists /ID# 236080

    Christchurch, Canterbury, 8013

  • Capital Eye Specialists /ID# 236112

    Wellington, 6011

Other trials in New Zealand

South Africa2 sites

  • Pretoria Eye Institute - Private Practice /ID# 235658

    Pretoria, Gauteng, 0083

  • Somerset Eye Specialist Medical & Surgical Centre /ID# 235540

    Somerset West, Western Cape, 7130

Other trials in South Africa

Australia1 site

  • Eye Surgery Associates /ID# 235873

    East Melbourne, Victoria, 3002

Other trials in Australia

Denmark1 site

  • Rigshospitalet Glostrup /ID# 235743

    Glostrup Municipality, Capital Region, 2600

Other trials in Denmark

Russia1 site

  • S. Fyodorov Eye Microsurgery Federal State Institution /ID# 235984

    Novosibirsk, Novosibirsk Oblast, 630071

Other trials in Russia

Sweden1 site

  • Norrlands University hospital /ID# 237553

    Umeå, Västerbotten County, 581 85

Other trials in Sweden

About this study

Official title: 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.

Being tested
Bimatoprost (SR)
Keywords
Open-Angle Glaucoma (OAG), Ocular Hypertension (OHT), Bimatoprost
Medical subject headings
Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bimatoprost (SR)Drug

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

    Fellow Eye: Standard of care or Bimatoprost SR.

Study groups in NCT03850782
Study groupRoleWhat they receive
Bimatoprost SR - Dose AExperimentalStudy 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.
Receives: Drug: Bimatoprost (SR)
Bimatoprost SR - Dose BExperimentalStudy 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.
Receives: Drug: Bimatoprost (SR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retreatment or rescue administered for IOP

    Treatment modality determined by investigator.

    Measured: Up to 48 months

  2. Number of patients experiencing a treatment emergent adverse event

    The number of patients who experienced one or more TEAE during the 48 month treatment period.

    Measured: Baseline up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2019
  2. Study start28 Feb 2019
  3. Primary completion8 Aug 2025
  4. Study completion8 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
515 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03850782
Sponsor's protocol ID
1698-301-007
Other IDs
2018-002574-52, 2022-502380-37-00, 2018
Acronym
TRITON
Status last verified
Aug 2025
First submitted
11 Feb 2019
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.
Expanded access
Available

Publications

  • Silverstein SM, Oddone F, Kolko M, Brinkmann CK, Christie WC, Bicket AK, Gous PNJ, Luebke J, Maram J, Nguyen A, Craven ER, Pu Y, Jiao J, Bejanian M, Robinson MR; TRITON Study Group. Safety and Longevity of Intraocular Pressure Control After Bimatoprost Implant Administration: Interim Analysis of a Phase 3b Clinical Trial (TRITON). Drugs. 2025 Apr;85(4):557-570. doi: 10.1007/s40265-025-02154-4. Epub 2025 Feb 22.

    PubMed 39985740

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bimatoprost (SR) in people with Open-Angle Glaucoma and Ocular Hypertension, run by AbbVie at 108 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States, Bulgaria, United Kingdom, Germany, Argentina and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retreatment or rescue administered for IOP (time frame: Up to 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03850782, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
TRITON Clinical Trial NCT03850782 | AzTrials