CClinicalTrials.gg
CompletedNCT03891446MAIAUpdated Jul 15, 2026

Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

A Phase 3 interventional study of Bimatoprost SR and Standard of Care in Open-Angle Glaucoma and Ocular Hypertension, sponsored by AbbVie. Completed at 124 sites in 26 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by AbbVie · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
455
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.

02

Conditions studied

  • Open-Angle Glaucoma
  • Ocular Hypertension

Keywords

  • Open-Angle Glaucoma
  • Ocular Hypertension
  • Bimatoprost
  • DURYSTA
03

In context

Glaucoma, Open-Angle

929 studies on the registry are indexed under Glaucoma, Open-Angle; 122 are open to participants now.

This study's enrollment of 455 is above the median of 80 across 700 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participants who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and received Bimatoprost SR.
  • Participants who completed (or exited early from) the open-label Phase 4 ARGOS study with no ongoing safety concerns, and received DURYSTA.

Exclusion criteria

Exclusion Criteria:

  • Female participants who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study.
  • Concurrent or anticipated enrollment in another investigational drug or device study during the present study.
  • Any condition which would preclude the participant's ability to comply with study requirements, including completion of the study.
  • Participants who were randomized to receive timolol eye drops in the study eye (control group) during the Phase 3 Bimatoprost Studies 192024-091 and -092.
  • For patients from the ARGOS lead-in study: history of prior incisional glaucoma surgeries and/or minimally invasive glaucoma surgical procedures in the study eye or treated fellow eye.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
455 participants (actual)

Study arms

  • Experimental
    Lead-in study 192024-091 or -092 or -095

    Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.

    Other: Standard of Care

  • Experimental
    Lead-in study 192024-093 Stage 1

    Participants who received 1, 2 or 3 administrations and participants in Stage 2 who received 1 Bimatoprost SR administration due to safety concern or received 2 administrations. Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.

    Other: Standard of Care

  • Experimental
    Lead-in study 192024-093 Stage 2

    Participants who received 1 Bimatoprost administration due to sustained efficacy: Study eye (Eye that received Bimatoprost SR in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.

    Drug: Bimatoprost SR · Other: Standard of Care

  • Experimental
    Lead-in study ARGOS

    Study eye (Eye that received Bimatoprost SR first in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Treated Fellow eye (Eye that received Bimatoprost SR second in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Untreated Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Untreated fellow eye will receive only standard of care, based on the investigator's judgment.

    Drug: Bimatoprost SR · Other: Standard of Care

Interventions

  • DrugBimatoprost SR

    Intraocular implant

    Also known as: DURYSTA

  • OtherStandard of Care

    Standard of care treatment based on investigator's judgement.

06

What researchers measure

Primary outcomes

  1. Duration of effect of Bimatoprost SR

    Retreatment or rescue administered for IOP lowering, determined by the investigator.

    Time frame: Approximately 24 months

  2. Number of patients experiencing a treatment emergent adverse event

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

    Time frame: Approximately 24 months

07

Study locations

124 sites
  • Trinity Research Group /ID# 240190
    Dothan, Alabama 36301, United States
  • Arizona Eye Center - West Ray Road /ID# 240239
    Chandler, Arizona 85224, United States
  • Arizona Glaucoma Specialists /ID# 240212
    Phoenix, Arizona 85050-4265, United States
  • M&M Eye Institute /ID# 240236
    Prescott, Arizona 86301, United States
  • Horizon Eye Specialists & Lasik Centers /ID# 240255
    Sun City, Arizona 85351, United States
  • Angeles Eye Institute /ID# 250397
    Culver City, California 90232, United States
  • Duplicate_Lakeside Vision Center /ID# 240204
    Irvine, California 92604, United States
  • Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196
    La Jolla, California 92093, United States
  • The Eye Research Foundation /ID# 240186
    Newport Beach, California 92663-3637, United States
  • North Bay Eye Associates Inc. /ID# 248912
    Petaluma, California 94954-2387, United States
  • Duplicate_Martel Eye Medical Group /ID# 240291
    Rancho Cordova, California 95670-2968, United States
  • The Clinical Trials Network (CTNx) /ID# 240284
    Redding, California 96001, United States
  • Sacramento Eye Consultants /ID# 240263
    Sacramento, California 95815, United States
  • Pacific Eye Associates /ID# 240234
    San Francisco, California 94115, United States
  • Wolstan & Goldberg Eye Associates /ID# 240221
    Torrance, California 90505, United States
  • Colorado Eye Institute /ID# 248910
    Colorado Springs, Colorado 80924-7003, United States
  • Specialty Retina Center /ID# 240254
    Coral Springs, Florida 33067, United States
  • Nature Coast Clinical Research - Crystal River /ID# 240334
    Crystal River, Florida 34429, United States
  • Bruce Segal, MD /ID# 240292
    Delray Beach, Florida 33484-6540, United States
  • Eye Associates of Fort Meyers /ID# 240218
    Fort Myers, Florida 33901, United States
  • Levenson Eye Associates- Riverside Park Place /ID# 240209
    Jacksonville, Florida 32204, United States
  • MedEye Associates /ID# 240333
    Miami, Florida 33143, United States
  • Logan Ophthalmic Research Inc. /ID# 240280
    Tamarac, Florida 33321, United States
  • International Research Center /ID# 240346
    Tampa, Florida 33603, United States
  • University of South Florida- Neuroscience Institute /ID# 250980
    Tampa, Florida 33613, United States
  • Duplicate_Emory University /ID# 240328
    Atlanta, Georgia 30322-1013, United States
  • Coastal Research Associates /ID# 240192
    Roswell, Georgia 30076, United States
  • Chicago Eye Specialists /ID# 240270
    Bedford Park, Illinois 60638, United States
  • University of Illinois Hospital and Health Sciences System /ID# 250981
    Chicago, Illinois 60607, United States
  • Kovach Eye Institute /ID# 250442
    Elmhurst, Illinois 60126-2821, United States
  • IN Univ School of Medicine /ID# 240294
    Indianapolis, Indiana 46202-2884, United States
  • The Eye Care Institute /ID# 240289
    Louisville, Kentucky 40206-1738, United States
  • Duplicate_Tulane University /ID# 240327
    New Orleans, Louisiana 70112-2699, United States
  • Clinical Eye Research of Boston LLC /ID# 240203
    Winchester, Massachusetts 01890, United States
  • Fraser Eye Center /ID# 240245
    Fraser, Michigan 48026, United States
  • Midwest Vision Research Foundation at Pepose Vision Institute /ID# 250402
    Chesterfield, Missouri 63017, United States
  • Tekwani Vision Center /ID# 240220
    St Louis, Missouri 63128, United States
  • Eye Associates of North Jersey /ID# 250445
    Dover, New Jersey 07801-1629, United States
  • Glaucoma Care Center /ID# 250978
    Livingston, New Jersey 07039, United States
  • Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 240181
    Newark, New Jersey 07103-2425, United States
  • Eye Associates of New Mexico /ID# 240216
    Albuquerque, New Mexico 87109, United States
  • Ophthalmic Consultants Long Island /ID# 240211
    Oceanside, New York 11572, United States
  • Rochester Ophthalmological Group PC /ID# 240290
    Rochester, New York 14618-2616, United States
  • Glaucoma associates/consultants of the capital region /ID# 240195
    Slingerlands, New York 12159, United States
  • Montefiore Hospital /ID# 240324
    The Bronx, New York 10467-2404, United States
  • Asheville Eye Associates /ID# 240202
    Asheville, North Carolina 28803, United States
  • Charlotte Eye Ear Nose And Throat Associates- Southpark /ID# 240339
    Charlotte, North Carolina 28210, United States
  • Albemarle Clinical Trials LLC /ID# 240219
    Elizabeth City, North Carolina 27909, United States
  • Private Practice - Dr. James D. Branch /ID# 240188
    Winston-Salem, North Carolina 27101, United States
  • Bergstrom Eye Research LLC /ID# 240257
    Fargo, North Dakota 58103, United States
  • Oklahoma Eye Surgeons /ID# 250430
    Oklahoma City, Oklahoma 73112, United States
  • Legacy Devers Eye Institute /ID# 240210
    Portland, Oregon 97210, United States
  • Scott and Christie and Associates /ID# 240189
    Cranberry Township, Pennsylvania 16066, United States
  • Eye Specialty Group /ID# 240241
    Memphis, Tennessee 38120, United States
  • Vanderbilt Eye Institute /ID# 252659
    Nashville, Tennessee 37232-0025, United States
  • Advancing Vision Research /ID# 240288
    Smyrna, Tennessee 37167, United States
  • Keystone Research LTD /ID# 240185
    Austin, Texas 78731-4203, United States
  • Houston Eye Associates /ID# 240340
    Houston, Texas 77025, United States
  • DCT Shah Eye Research Institut /ID# 240306
    Mission, Texas 78572, United States
  • Plano Office /ID# 240243
    Plano, Texas 75093, United States
  • San Antonio Eye Center /ID# 240238
    San Antonio, Texas 78215, United States
  • Eye associates /ID# 240265
    San Antonio, Texas 78229, United States
  • Medical Center Ophthalmology Associates /ID# 240208
    San Antonio, Texas 78240-1502, United States
  • Emerson Clinical Research Institute - Falls Church /ID# 240274
    Falls Church, Virginia 22046, United States
  • Piedmont Eye Center /ID# 240187
    Lynchburg, Virginia 24502, United States
  • Vistar Eye Center /ID# 240198
    Roanoke, Virginia 24011, United States
  • Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247
    CABA, Buenos Aires 1122, Argentina
  • Clinica Privada de Ojos /ID# 240272
    Mar del Plata, Buenos Aires 7600, Argentina
  • Hospital Universitario Austral /ID# 240331
    Pilar, Buenos Aires 1629, Argentina
  • Oftalmología Global /ID# 240244
    Rosario, Santa Fe Province 2000, Argentina
  • Oftar Mendoza /ID# 240308
    Mendoza, 1019, Argentina
  • Universitair Ziekenhuis Leuven /ID# 240312
    Leuven, Vlaams-Brabant 3000, Belgium
  • Hospital de Olhos de Mato Grosso Do Sul /ID# 240276
    Campo Grande, Mato Grosso do Sul 79002-075, Brazil
  • Clinica De Oftalmologia Nova Campinas /ID# 240271
    Campinas, São Paulo 13092-108, Brazil
  • Hospital Oftalmologico Medicina dos Olhos /ID# 240277
    Osasco, São Paulo 0601-8180, Brazil
  • Hospital Sao Paulo /ID# 240278
    São Paulo, 04023-062, Brazil
  • Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 240336
    Halifax, Nova Scotia B3H 2Y9, Canada
  • Ophthalmic Consultant Centres /ID# 240205
    Mississauga, Ontario L4W 1W9, Canada
  • Clinica de Oftalmologia Sandiego /ID# 240233
    Medellín, Antioquia 050016, Colombia
  • Fundacion Oftalmologica Nacional /ID# 240226
    Bogotá, Bogota D.C. 110231, Colombia
  • Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634
    Bucaramanga, Santander Department 681004, Colombia
  • Ocni klinika Pardubice /ID# 240347
    Pardubice, 530 02, Czechia
  • Rigshospitalet Glostrup /ID# 240330
    Glostrup Municipality, Capital Region 2600, Denmark
  • Bostan Diagnostic Eye Center /ID# 240268
    Cairo, Egypt
  • Duplicate_Ain Shams University Hospital /ID# 240338
    Cairo, Egypt
  • CHU Bordeaux - Hopital Pellegrin /ID# 240316
    Bordeaux, New Aquitaine 33076, France
  • Centre Ophtalmologique Pôle Vision /ID# 240256
    Écully, Rhone 69130, France
  • Internationale Innovative Ophthalmochirurgie /ID# 240232
    Düsseldorf, North Rhine-Westphalia 40212, Germany
  • Universitaetsklinikum Magdeburg /ID# 240314
    Magdeburg, 39120, Germany
  • The Chinese University of Hong Kong /ID# 240283
    Hong Kong, Hong Kong
  • Galilee Medical Center /ID# 251967
    Nahariya, Northern District 2210001, Israel
  • Tel Aviv Sourasky Medical Center /ID# 240311
    Tel Aviv, Tel Aviv 6423906, Israel
  • Rambam Health Care Campus /ID# 240332
    Haifa, 3109601, Israel
  • Bnai Zion Medical Center /ID# 240297
    Haifa, 3339419, Israel
  • The Lady Davis Carmel Medical Center /ID# 240293
    Haifa, 34362, Israel
  • AOU Policlinico G. Rodolico - San Marco /ID# 240305
    Catania, 95123, Italy
  • ASL 2 Abruzzo Lanciano-Vasto-Chieti /ID# 240217
    Chieti, 67100, Italy
  • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 240310
    Perugia, 06156, Italy
  • Azienda Ospedaliero Universitaria Pisana /ID# 240301
    Pisa, 56126, Italy
  • Capital Eye Specialists /ID# 240259
    Wellington, 6011, New Zealand

Showing the first 100 of 124 sites across 26 countries.

08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03891446
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Mar 27, 2019
Start date
Mar 27, 2019
Primary completion
Jun 19, 2026
Completion
Jun 19, 2026
Last update
Jul 15, 2026

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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