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

NCT ID: NCT03850782

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

515 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2025-08-08

Brief Summary

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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.

Detailed Description

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Conditions

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Open-Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Bimatoprost (SR)

Intervention Type DRUG

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

Fellow Eye: Standard of care or Bimatoprost SR.

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.

Group Type EXPERIMENTAL

Bimatoprost (SR)

Intervention Type DRUG

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

Fellow Eye: Standard of care or Bimatoprost SR.

Interventions

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Bimatoprost (SR)

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

Fellow Eye: Standard of care or Bimatoprost SR.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Horizon Eye Specialists & Lasik Centers /ID# 235240

Sun City, Arizona, United States

Site Status

Atlantis Eye Care /ID# 235530

Huntington Beach, California, United States

Site Status

Lakeside Vision Center /ID# 234970

Irvine, California, United States

Site Status

Global Research Foundation /ID# 237350

Los Angeles, California, United States

Site Status

The Eye Research Foundation /ID# 234521

Newport Beach, California, United States

Site Status

Byers Eye Institute Stanford /ID# 235544

Palo Alto, California, United States

Site Status

Foothill Eye Institute /ID# 235640

Pasadena, California, United States

Site Status

Connecticut Eye Consultants P.C. /ID# 234981

Danbury, Connecticut, United States

Site Status

Advanced Research, LLC /ID# 236045

Deerfield Beach, Florida, United States

Site Status

Segal Drug Trials, Inc /ID# 235784

Delray Beach, Florida, United States

Site Status

International Research Center /ID# 238050

Tampa, Florida, United States

Site Status

Thomas Eye Group PC /ID# 235737

Sandy Springs, Georgia, United States

Site Status

Indiana University - Glick Eye Institute /ID# 235886

Indianapolis, Indiana, United States

Site Status

Retina Partners Midwest, PC /ID# 237876

Indianapolis, Indiana, United States

Site Status

Tulane University School of Medicine /ID# 237632

New Orleans, Louisiana, United States

Site Status

Ophthalmic Consultants of Boston /ID# 236534

Boston, Massachusetts, United States

Site Status

Clinical Eye Research of Boston LLC /ID# 234966

Winchester, Massachusetts, United States

Site Status

University of Michigan, Kellogg Eye Center /ID# 236496

Ann Arbor, Michigan, United States

Site Status

Fraser Eye Center /ID# 235790

Fraser, Michigan, United States

Site Status

Silverstein Eye Centers /ID# 237881

Kansas City, Missouri, United States

Site Status

Moyes Eye Centers /ID# 234989

Kansas City, Missouri, United States

Site Status

Alterman Modi & Wolter /ID# 235248

Poughkeepsie, New York, United States

Site Status

The Ohio State University /ID# 236790

Columbus, Ohio, United States

Site Status

AMA Eyes Research Institute /ID# 235542

Marysville, Ohio, United States

Site Status

Dean McGee Eye Institute /ID# 236823

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma Eye Surgeons /ID# 235849

Oklahoma City, Oklahoma, United States

Site Status

Drs Fine Hoffman & Sims LLC /ID# 235918

Eugene, Oregon, United States

Site Status

Ophthalmic Partners, PC /ID# 235741

Bala-Cynwyd, Pennsylvania, United States

Site Status

Scott and Christie and Associates /ID# 234593

Cranberry Township, Pennsylvania, United States

Site Status

Black Hills Regional Eye Institute /ID# 235075

Rapid City, South Dakota, United States

Site Status

Vance Thompson Vision /ID# 235072

Sioux Falls, South Dakota, United States

Site Status

Eye Specialty Group /ID# 235721

Memphis, Tennessee, United States

Site Status

Vanderbilt University Medical Center /ID# 237177

Nashville, Tennessee, United States

Site Status

Advancing Vision Research /ID# 236681

Smyrna, Tennessee, United States

Site Status

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

Austin, Texas, United States

Site Status

Medical Center Ophthalmology Associates - Keystone Research /ID# 235787

San Antonio, Texas, United States

Site Status

Southern Utah Medical Research /ID# 235602

St. George, Utah, United States

Site Status

Piedmont Eye Center /ID# 234534

Lynchburg, Virginia, United States

Site Status

Consultorio Oftalmologico Dr. Fabian Lerner /ID# 235855

CABA, Buenos Aires, Argentina

Site Status

Hospital Universitario Austral /ID# 237727

Pilar, Buenos Aires, Argentina

Site Status

Centro oftalmologico Dr Charles /ID# 235881

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

Site Status

Oftalmología Global /ID# 239187

Rosario, Santa Fe Province, Argentina

Site Status

Hospital Italiano /ID# 235851

Buenos Aires, , Argentina

Site Status

Centro Privado de Ojos /ID# 241283

Ciudad Autonoma Buenos Aires, , Argentina

Site Status

Oftar Mendoza /ID# 240535

Mendoza, , Argentina

Site Status

Eye Surgery Associates /ID# 235873

East Melbourne, Victoria, Australia

Site Status

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

Sofiya, Sofia, Bulgaria

Site Status

Diagnostic Consultative Center Aleksandrovska /ID# 238105

Sofiya, Sofia, Bulgaria

Site Status

Medical Center Oxycom Burgas /ID# 235580

Burgas, , Bulgaria

Site Status

UMHAT Sveti Georgi /ID# 237027

Plovdiv, , Bulgaria

Site Status

MHAT Hadzhi Dimitar /ID# 238248

Sliven, , Bulgaria

Site Status

MHAT Dr. Bratan Shukerov /ID# 235498

Smolyan, , Bulgaria

Site Status

Medical center for eye healt Focus Ltd /ID# 235575

Sofia, , Bulgaria

Site Status

Pentagram Eye Hospital /ID# 235813

Sofia, , Bulgaria

Site Status

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

Sofia, , Bulgaria

Site Status

St. Sofia Hospital /ID# 235525

Sofia, , Bulgaria

Site Status

Medical Center -Verea /ID# 235494

Stara Zagora, , Bulgaria

Site Status

Medical center Orfey /ID# 237344

Stara Zagora, , Bulgaria

Site Status

MHAT Trakia /ID# 238137

Stara Zagora, , Bulgaria

Site Status

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

Varna, , Bulgaria

Site Status

Všeobecná Fakultní Nemocnice v Praze /ID# 234422

Prague, Praha 17, Czechia

Site Status

Ocni klinika Pardubice /ID# 235944

Pardubice, , Czechia

Site Status

Fakultni nemocnice Kralovske Vinohrady /ID# 234323

Prague, , Czechia

Site Status

Rigshospitalet Glostrup /ID# 235743

Glostrup Municipality, Capital Region, Denmark

Site Status

Universitatsklinikum Freiburg /ID# 238048

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Universitaetsmedizin Goettingen /ID# 237377

Göttingen, Lower Saxony, Germany

Site Status

Universitaetsmedizin Rostock /ID# 237263

Rostock, Mecklenburg-Vorpommern, Germany

Site Status

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 237069

Kiel, Schleswig-Holstein, Germany

Site Status

Klinikum Dresden Friedrichstadt /ID# 235308

Dresden, , Germany

Site Status

Asklepios Kinik Nord - Heidberg Augenklinik /ID# 235955

Hamburg, , Germany

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St. Franziskus-Hospital /ID# 237714

Münster, , Germany

Site Status

Dietrich-Bonhoeffer-Klinikum /ID# 235262

Neubrandenburg, , Germany

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Augenzentrum Dr Hamacher /ID# 235537

Starnberg, , Germany

Site Status

Gyongyosi Bugat Pal Korhaz /ID# 238144

Gyöngyös, Heves County, Hungary

Site Status

Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 237383

Szombathely, Vas County, Hungary

Site Status

Budapest Retina Intezet /ID# 235950

Budapest, , Hungary

Site Status

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

Budapest, , Hungary

Site Status

Royal Victoria Eye and Ear Hospital /ID# 235546

Dublin, , Ireland

Site Status

Institute of Eye Surgery /ID# 235547

Waterford, , Ireland

Site Status

University of Catanzaro /ID# 238066

Catanzaro, Calabria, Italy

Site Status

Sapienza University of Rome - Polo Pontino /ID# 237451

Terracina, Latina, Italy

Site Status

Duplicate_Eye Clinic University of Catania /ID# 235573

Catania, , Italy

Site Status

Duplicate_Ospedale Ss. Annunziata /ID# 236587

Chieti, , Italy

Site Status

Fondazione IRCCS Policlinico San Matteo /ID# 236909

Pavia, , Italy

Site Status

University of Perugia /ID# 235811

Perugia, , Italy

Site Status

Fondazione Bietti - Ospedale Britannico /ID# 235495

Rome, , Italy

Site Status

Southern Eye Specialists /ID# 236080

Christchurch, Canterbury, New Zealand

Site Status

Capital Eye Specialists /ID# 236112

Wellington, , New Zealand

Site Status

Wojskowy Instytut Medyczny /ID# 237031

Warsaw, Masovian Voivodeship, Poland

Site Status

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

Gdansk, Pomeranian Voivodeship, Poland

Site Status

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

Olsztyn, Warmian-Masurian Voivodeship, Poland

Site Status

Gabinet Okulistyczny Edward Wylegala /ID# 235946

Katowice, , Poland

Site Status

Medical Center Julianow /ID# 235961

Lodz, Łódź Voivodeship, Poland

Site Status

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

Novosibirsk, Novosibirsk Oblast, Russia

Site Status

Pretoria Eye Institute - Private Practice /ID# 235658

Pretoria, Gauteng, South Africa

Site Status

Somerset Eye Specialist Medical & Surgical Centre /ID# 235540

Somerset West, Western Cape, South Africa

Site Status

Norrlands University hospital /ID# 237553

Umeå, Västerbotten County, Sweden

Site Status

Addenbrookes Hospital /ID# 238255

Cambridge, Cambridgeshire, United Kingdom

Site Status

Mid Essex Hospitals NHS Trust /ID# 237776

Chelmsford, Essex, United Kingdom

Site Status

The Princess Alexandra NHS Trust /ID# 234433

Harlow, Essex, United Kingdom

Site Status

Kings College Hospital NHS Foundation Trust /ID# 237275

London, Greater London, United Kingdom

Site Status

York Hospital /ID# 237683

York, North Yorkshire, United Kingdom

Site Status

Oxford University Hospitals NHS Foundation Trust /ID# 237282

Oxford, Oxfordshire, United Kingdom

Site Status

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

Colchester, , United Kingdom

Site Status

Mid-Cheshire Hospitals NHS Trust /ID# 235418

Crewe, , United Kingdom

Site Status

Liverpool University Hospitals NHS Foundation Trust /ID# 237095

Liverpool, , United Kingdom

Site Status

Liverpool University Hospitals NHS Foundation Trust /ID# 237321

Liverpool, , United Kingdom

Site Status

Central Middlesex Hospital /ID# 236216

London, , United Kingdom

Site Status

Countries

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United States Argentina Australia Bulgaria Czechia Denmark Germany Hungary Ireland Italy New Zealand Poland Russia South Africa Sweden United Kingdom

References

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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.

Reference Type DERIVED
PMID: 39985740 (View on PubMed)

Related Links

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Other Identifiers

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2018-002574-52

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2022-502380-37-00

Identifier Type: OTHER

Identifier Source: secondary_id

1698-301-007

Identifier Type: -

Identifier Source: org_study_id

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