Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
TRITON
A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
3 other identifiers
interventional
515
16 countries
108
Brief 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 than medication efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2019
Longer than P75 for phase_3
108 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2019
CompletedFirst Posted
Study publicly available on registry
February 22, 2019
CompletedStudy Start
First participant enrolled
February 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2025
CompletedAugust 19, 2025
August 1, 2025
6.4 years
February 11, 2019
August 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Retreatment or rescue administered for IOP
Treatment modality determined by investigator.
Up to 48 months
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.
Baseline up to 48 months
Study Arms (2)
Bimatoprost SR - Dose A
EXPERIMENTALStudy 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.
Bimatoprost SR - Dose B
EXPERIMENTALStudy 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.
Interventions
Study Eye: Cycles 1 - 3 administrations through the PRN treatment period. Fellow Eye: Standard of care or Bimatoprost SR.
Eligibility Criteria
You may qualify if:
- \- Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular pressure-lowering treatment.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (108)
Horizon Eye Specialists & Lasik Centers /ID# 235240
Sun City, Arizona, 85351, United States
Atlantis Eye Care /ID# 235530
Huntington Beach, California, 92647, United States
Lakeside Vision Center /ID# 234970
Irvine, California, 92604, United States
Global Research Foundation /ID# 237350
Los Angeles, California, 90041-1718, United States
The Eye Research Foundation /ID# 234521
Newport Beach, California, 92663-3637, United States
Byers Eye Institute Stanford /ID# 235544
Palo Alto, California, 94303, United States
Foothill Eye Institute /ID# 235640
Pasadena, California, 91107, United States
Connecticut Eye Consultants P.C. /ID# 234981
Danbury, Connecticut, 06810, United States
Advanced Research, LLC /ID# 236045
Deerfield Beach, Florida, 33064-1342, United States
Segal Drug Trials, Inc /ID# 235784
Delray Beach, Florida, 33484, United States
International Research Center /ID# 238050
Tampa, Florida, 33603, United States
Thomas Eye Group PC /ID# 235737
Sandy Springs, Georgia, 30328, United States
Indiana University - Glick Eye Institute /ID# 235886
Indianapolis, Indiana, 46202, United States
Retina Partners Midwest, PC /ID# 237876
Indianapolis, Indiana, 46290, United States
Tulane University School of Medicine /ID# 237632
New Orleans, Louisiana, 70112, United States
Ophthalmic Consultants of Boston /ID# 236534
Boston, Massachusetts, 02129, United States
Clinical Eye Research of Boston LLC /ID# 234966
Winchester, Massachusetts, 01890, United States
University of Michigan, Kellogg Eye Center /ID# 236496
Ann Arbor, Michigan, 48105, United States
Fraser Eye Center /ID# 235790
Fraser, Michigan, 48026, United States
Silverstein Eye Centers /ID# 237881
Kansas City, Missouri, 64034, United States
Moyes Eye Centers /ID# 234989
Kansas City, Missouri, 64154, United States
Alterman Modi & Wolter /ID# 235248
Poughkeepsie, New York, 12603-2455, United States
The Ohio State University /ID# 236790
Columbus, Ohio, 43210-1257, United States
AMA Eyes Research Institute /ID# 235542
Marysville, Ohio, 43040, United States
Dean McGee Eye Institute /ID# 236823
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Eye Surgeons /ID# 235849
Oklahoma City, Oklahoma, 73112, United States
Drs Fine Hoffman & Sims LLC /ID# 235918
Eugene, Oregon, 97401, United States
Ophthalmic Partners, PC /ID# 235741
Bala-Cynwyd, Pennsylvania, 19004, United States
Scott and Christie and Associates /ID# 234593
Cranberry Township, Pennsylvania, 16066, United States
Black Hills Regional Eye Institute /ID# 235075
Rapid City, South Dakota, 57701, United States
Vance Thompson Vision /ID# 235072
Sioux Falls, South Dakota, 57108, United States
Eye Specialty Group /ID# 235721
Memphis, Tennessee, 38120, United States
Vanderbilt University Medical Center /ID# 237177
Nashville, Tennessee, 37232-0011, United States
Advancing Vision Research /ID# 236681
Smyrna, Tennessee, 37167, United States
ATX Clinical Trials Inc. dba Keystone Research /ID# 235868
Austin, Texas, 78731, United States
Medical Center Ophthalmology Associates - Keystone Research /ID# 235787
San Antonio, Texas, 78240, United States
Southern Utah Medical Research /ID# 235602
St. George, Utah, 84790, United States
Piedmont Eye Center /ID# 234534
Lynchburg, Virginia, 24502, United States
Consultorio Oftalmologico Dr. Fabian Lerner /ID# 235855
CABA, Buenos Aires, 1122, Argentina
Hospital Universitario Austral /ID# 237727
Pilar, Buenos Aires, 1629, Argentina
Centro oftalmologico Dr Charles /ID# 235881
Ciudad de Buenos Aires, Buenos Aires F.D., 1116, Argentina
Oftalmología Global /ID# 239187
Rosario, Santa Fe Province, 2000, Argentina
Hospital Italiano /ID# 235851
Buenos Aires, 1181, Argentina
Centro Privado de Ojos /ID# 241283
Ciudad Autonoma Buenos Aires, 1033, Argentina
Oftar Mendoza /ID# 240535
Mendoza, 1019, Argentina
Eye Surgery Associates /ID# 235873
East Melbourne, Victoria, 3002, Australia
Multiprofile Hospital for Active Treatment "Lozenetz" /ID# 244053
Sofiya, Sofia, 1407, Bulgaria
Diagnostic Consultative Center Aleksandrovska /ID# 238105
Sofiya, Sofia, 1431, Bulgaria
Medical Center Oxycom Burgas /ID# 235580
Burgas, 8008, Bulgaria
UMHAT Sveti Georgi /ID# 237027
Plovdiv, 4002, Bulgaria
MHAT Hadzhi Dimitar /ID# 238248
Sliven, 8800, Bulgaria
MHAT Dr. Bratan Shukerov /ID# 235498
Smolyan, 4700, Bulgaria
Medical center for eye healt Focus Ltd /ID# 235575
Sofia, 1303, Bulgaria
Pentagram Eye Hospital /ID# 235813
Sofia, 1309, Bulgaria
Specialized Hospital for Active Treatment in Ocular Diseases "Zrenie" /ID# 235500
Sofia, 1408, Bulgaria
St. Sofia Hospital /ID# 235525
Sofia, 1618, Bulgaria
Medical Center -Verea /ID# 235494
Stara Zagora, 6000, Bulgaria
Medical center Orfey /ID# 237344
Stara Zagora, 6000, Bulgaria
MHAT Trakia /ID# 238137
Stara Zagora, 6004, Bulgaria
Specialized Ophthalmological Hospital for Active Treatment - Varna /ID# 235962
Varna, 9002, Bulgaria
Všeobecná Fakultní Nemocnice v Praze /ID# 234422
Prague, Praha 17, 128 00, Czechia
Ocni klinika Pardubice /ID# 235944
Pardubice, 530 02, Czechia
Fakultni nemocnice Kralovske Vinohrady /ID# 234323
Prague, 100 34, Czechia
Rigshospitalet Glostrup /ID# 235743
Glostrup Municipality, Capital Region, 2600, Denmark
Universitatsklinikum Freiburg /ID# 238048
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Universitaetsmedizin Goettingen /ID# 237377
Göttingen, Lower Saxony, 37075, Germany
Universitaetsmedizin Rostock /ID# 237263
Rostock, Mecklenburg-Vorpommern, 18057, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 237069
Kiel, Schleswig-Holstein, 24105, Germany
Klinikum Dresden Friedrichstadt /ID# 235308
Dresden, 01067, Germany
Asklepios Kinik Nord - Heidberg Augenklinik /ID# 235955
Hamburg, 22417, Germany
St. Franziskus-Hospital /ID# 237714
Münster, 48145, Germany
Dietrich-Bonhoeffer-Klinikum /ID# 235262
Neubrandenburg, 17036, Germany
Augenzentrum Dr Hamacher /ID# 235537
Starnberg, 82319, Germany
Gyongyosi Bugat Pal Korhaz /ID# 238144
Gyöngyös, Heves County, 3200, Hungary
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 237383
Szombathely, Vas County, 9700, Hungary
Budapest Retina Intezet /ID# 235950
Budapest, 1133, Hungary
Jahn Ferenc Del-pesti Korhaz es Rendelointezet /ID# 237111
Budapest, 1204, Hungary
Royal Victoria Eye and Ear Hospital /ID# 235546
Dublin, 2, Ireland
Institute of Eye Surgery /ID# 235547
Waterford, X91 DH9W, Ireland
University of Catanzaro /ID# 238066
Catanzaro, Calabria, 88100, Italy
Sapienza University of Rome - Polo Pontino /ID# 237451
Terracina, Latina, 04019, Italy
Duplicate_Eye Clinic University of Catania /ID# 235573
Catania, 95123, Italy
Duplicate_Ospedale Ss. Annunziata /ID# 236587
Chieti, 66100, Italy
Fondazione IRCCS Policlinico San Matteo /ID# 236909
Pavia, 27100, Italy
University of Perugia /ID# 235811
Perugia, 06156, Italy
Fondazione Bietti - Ospedale Britannico /ID# 235495
Rome, 00184, Italy
Southern Eye Specialists /ID# 236080
Christchurch, Canterbury, 8013, New Zealand
Capital Eye Specialists /ID# 236112
Wellington, 6011, New Zealand
Wojskowy Instytut Medyczny /ID# 237031
Warsaw, Masovian Voivodeship, 04-349, Poland
Optimum Profesorskie Centrum Okulistyki SP.z.o.o. /ID# 237076
Gdansk, Pomeranian Voivodeship, 80-809, Poland
Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 235928
Olsztyn, Warmian-Masurian Voivodeship, 10-424, Poland
Gabinet Okulistyczny Edward Wylegala /ID# 235946
Katowice, 40-594, Poland
Medical Center Julianow /ID# 235961
Lodz, Łódź Voivodeship, 91-485, Poland
S. Fyodorov Eye Microsurgery Federal State Institution /ID# 235984
Novosibirsk, Novosibirsk Oblast, 630071, Russia
Pretoria Eye Institute - Private Practice /ID# 235658
Pretoria, Gauteng, 0083, South Africa
Somerset Eye Specialist Medical & Surgical Centre /ID# 235540
Somerset West, Western Cape, 7130, South Africa
Norrlands University hospital /ID# 237553
Umeå, Västerbotten County, 581 85, Sweden
Addenbrookes Hospital /ID# 238255
Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
Mid Essex Hospitals NHS Trust /ID# 237776
Chelmsford, Essex, CM1 7ET, United Kingdom
The Princess Alexandra NHS Trust /ID# 234433
Harlow, Essex, CM20 1QX, United Kingdom
Kings College Hospital NHS Foundation Trust /ID# 237275
London, Greater London, SE5 9RS, United Kingdom
York Hospital /ID# 237683
York, North Yorkshire, YO31 8HE, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 237282
Oxford, Oxfordshire, OX3 9DU, United Kingdom
East Suffolk and North Essex NHS Foundation Trust /ID# 234657
Colchester, CO4 5JL, United Kingdom
Mid-Cheshire Hospitals NHS Trust /ID# 235418
Crewe, CW1 4QJ, United Kingdom
Liverpool University Hospitals NHS Foundation Trust /ID# 237095
Liverpool, L7 8XP, United Kingdom
Liverpool University Hospitals NHS Foundation Trust /ID# 237321
Liverpool, L7 8XP, United Kingdom
Central Middlesex Hospital /ID# 236216
London, NW10 7NS, United Kingdom
Related Publications (1)
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.
PMID: 39985740DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
February 11, 2019
First Posted
February 22, 2019
Study Start
February 28, 2019
Primary Completion
August 8, 2025
Study Completion
August 8, 2025
Last Updated
August 19, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.