Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
NCT ID: NCT03891446
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
455 participants
INTERVENTIONAL
2019-03-27
2026-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
NCT03850782
Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension
NCT02247804
18 Month Prospective Efficacy and Safety Study of Bimatoprost Intracameral Implant (DURYSTA)
NCT04647214
Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension
NCT02250651
A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension
NCT04285580
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Standard of Care
Standard of care treatment based on investigator's judgement.
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.
Standard of Care
Standard of care treatment based on investigator's judgement.
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.
Bimatoprost SR
Intraocular implant
Standard of Care
Standard of care treatment based on investigator's judgement.
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.
Bimatoprost SR
Intraocular implant
Standard of Care
Standard of care treatment based on investigator's judgement.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bimatoprost SR
Intraocular implant
Standard of Care
Standard of care treatment based on investigator's judgement.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants who completed (or exited early from) the open-label Phase 4 ARGOS study with no ongoing safety concerns, and received DURYSTA.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Trinity Research Group /ID# 240190
Dothan, Alabama, United States
Arizona Eye Center - West Ray Road /ID# 240239
Chandler, Arizona, United States
Arizona Glaucoma Specialists /ID# 240212
Phoenix, Arizona, United States
M&M Eye Institute /ID# 240236
Prescott, Arizona, United States
Horizon Eye Specialists & Lasik Centers /ID# 240255
Sun City, Arizona, United States
Angeles Eye Institute /ID# 250397
Culver City, California, United States
Duplicate_Lakeside Vision Center /ID# 240204
Irvine, California, United States
Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196
La Jolla, California, United States
The Eye Research Foundation /ID# 240186
Newport Beach, California, United States
North Bay Eye Associates Inc. /ID# 248912
Petaluma, California, United States
Duplicate_Martel Eye Medical Group /ID# 240291
Rancho Cordova, California, United States
The Clinical Trials Network (CTNx) /ID# 240284
Redding, California, United States
Sacramento Eye Consultants /ID# 240263
Sacramento, California, United States
Pacific Eye Associates /ID# 240234
San Francisco, California, United States
Wolstan & Goldberg Eye Associates /ID# 240221
Torrance, California, United States
Colorado Eye Institute /ID# 248910
Colorado Springs, Colorado, United States
Specialty Retina Center /ID# 240254
Coral Springs, Florida, United States
Nature Coast Clinical Research - Crystal River /ID# 240334
Crystal River, Florida, United States
Bruce Segal, MD /ID# 240292
Delray Beach, Florida, United States
Eye Associates of Fort Meyers /ID# 240218
Fort Myers, Florida, United States
Levenson Eye Associates Inc. /ID# 240209
Jacksonville, Florida, United States
MedEye Associates /ID# 240333
Miami, Florida, United States
Logan Ophthalmic Research Inc. /ID# 240280
Tamarac, Florida, United States
International Research Center /ID# 240346
Tampa, Florida, United States
University of South Florida- Neuroscience Institute /ID# 250980
Tampa, Florida, United States
Duplicate_Emory University /ID# 240328
Atlanta, Georgia, United States
Coastal Research Associates /ID# 240192
Roswell, Georgia, United States
Chicago Eye Specialists /ID# 240270
Bedford Park, Illinois, United States
University of Illinois at Chicago /ID# 250981
Chicago, Illinois, United States
Kovach Eye Institute /ID# 250442
Elmhurst, Illinois, United States
IN Univ School of Medicine /ID# 240294
Indianapolis, Indiana, United States
The Eye Care Institute /ID# 240289
Louisville, Kentucky, United States
Duplicate_Tulane University /ID# 240327
New Orleans, Louisiana, United States
Clinical Eye Research of Boston LLC /ID# 240203
Winchester, Massachusetts, United States
Fraser Eye Center /ID# 240245
Fraser, Michigan, United States
Midwest Vision Research Foundation at Pepose Vision Institute /ID# 250402
Chesterfield, Missouri, United States
Tekwani Vision Center /ID# 240220
St Louis, Missouri, United States
Eye Associates of North Jersey /ID# 250445
Dover, New Jersey, United States
Glaucoma Care Center /ID# 250978
Livingston, New Jersey, United States
Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 240181
Newark, New Jersey, United States
Eye Associates of New Mexico /ID# 240216
Albuquerque, New Mexico, United States
Ophthalmic Consultants Long Island /ID# 240211
Oceanside, New York, United States
Rochester Ophthalmological Group PC /ID# 240290
Rochester, New York, United States
Glaucoma associates/consultants of the capital region /ID# 240195
Slingerlands, New York, United States
Montefiore Hospital /ID# 240324
The Bronx, New York, United States
Asheville Eye Associates /ID# 240202
Asheville, North Carolina, United States
Charlotte Eye,Ear,Nose Throat /ID# 240339
Belmont, North Carolina, United States
Albemarle Clinical Trials LLC /ID# 240219
Elizabeth City, North Carolina, United States
Private Practice - Dr. James D. Branch /ID# 240188
Winston-Salem, North Carolina, United States
Bergstrom Eye Research LLC /ID# 240257
Fargo, North Dakota, United States
Oklahoma Eye Surgeons /ID# 250430
Oklahoma City, Oklahoma, United States
Legacy Devers Eye Institute /ID# 240210
Portland, Oregon, United States
Scott and Christie and Associates /ID# 240189
Cranberry Township, Pennsylvania, United States
Eye Specialty Group /ID# 240241
Memphis, Tennessee, United States
Vanderbilt Eye Institute /ID# 252659
Nashville, Tennessee, United States
Advancing Vision Research /ID# 240288
Smyrna, Tennessee, United States
Keystone Research LTD /ID# 240185
Austin, Texas, United States
Houston Eye Associates /ID# 240340
Houston, Texas, United States
DCT Shah Eye Research Institut /ID# 240306
Mission, Texas, United States
Plano Office /ID# 240243
Plano, Texas, United States
San Antonio Eye Center /ID# 240238
San Antonio, Texas, United States
Eye associates /ID# 240265
San Antonio, Texas, United States
Medical Center Ophthalmology Associates /ID# 240208
San Antonio, Texas, United States
Emerson Clinical Research Institute. LLC /ID# 240274
Falls Church, Virginia, United States
Piedmont Eye Center /ID# 240187
Lynchburg, Virginia, United States
Vistar Eye Center /ID# 240198
Roanoke, Virginia, United States
Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247
CABA, Buenos Aires, Argentina
Clinica Privada de Ojos /ID# 240272
Mar del Plata, Buenos Aires, Argentina
Hospital Universitario Austral /ID# 240331
Pilar, Buenos Aires, Argentina
Oftalmología Global /ID# 240244
Rosario, Santa Fe Province, Argentina
Oftar Mendoza /ID# 240308
Mendoza, , Argentina
Universitair Ziekenhuis Leuven /ID# 240312
Leuven, Vlaams-Brabant, Belgium
Hospital de Olhos de Mato Grosso Do Sul /ID# 240276
Campo Grande, Mato Grosso do Sul, Brazil
Clinica De Oftalmologia Nova Campinas /ID# 240271
Campinas, São Paulo, Brazil
Hospital Oftalmologico Medicina dos Olhos /ID# 240277
Osasco, São Paulo, Brazil
Hospital Sao Paulo /ID# 240278
São Paulo, , Brazil
Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 240336
Halifax, Nova Scotia, Canada
Ophthalmic Consultant Centres /ID# 240205
Mississauga, Ontario, Canada
Clinica de Oftalmologia Sandiego /ID# 240233
Medellín, Antioquia, Colombia
Fundacion Oftalmologica Nacional /ID# 240226
Bogotá, Bogota D.C., Colombia
Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634
Bucaramanga, Santander Department, Colombia
Ocni klinika Pardubice /ID# 240347
Pardubice, , Czechia
Rigshospitalet Glostrup /ID# 240330
Glostrup Municipality, Capital Region, 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, Nouvelle-Aquitaine, France
Centre Ophtalmologique Pôle Vision /ID# 240256
Écully, Rhone, France
Internationale Innovative Ophthalmochirurgie /ID# 240232
Düsseldorf, North Rhine-Westphalia, Germany
Universitaetsklinikum Magdeburg /ID# 240314
Magdeburg, , Germany
The Chinese University of Hong Kong /ID# 240283
Hong Kong, , Hong Kong
Galilee Medical Center /ID# 251967
Nahariya, Northern District, Israel
Tel Aviv Sourasky Medical Center /ID# 240311
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus /ID# 240332
Haifa, , Israel
Bnai Zion Medical Center /ID# 240297
Haifa, , Israel
The Lady Davis Carmel Medical Center /ID# 240293
Haifa, , Israel
AOU Policlinico G. Rodolico - San Marco /ID# 240305
Catania, , Italy
ASL 2 Abruzzo Lanciano-Vasto-Chieti /ID# 240217
Chieti, , Italy
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 240310
Perugia, , Italy
Azienda Ospedaliero Universitaria Pisana /ID# 240301
Pisa, , Italy
Capital Eye Specialists /ID# 240259
Wellington, , New Zealand
Centro Oftalmologico Macula Diagnostico and Tratamiento /ID# 240269
Lima, , Peru
Asian Eye Institute /ID# 240213
Makati City, , Philippines
Asian Eye Institute /ID# 240214
Makati City, , Philippines
Peregrine Eye and Laser Institute /ID# 240260
Makati City, , Philippines
Oftalmika sp. z o.o. /ID# 240201
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Klinika Diagnostyki i Mikrochirurgii Jaskry /ID# 240258
Lublin, Lublin Voivodeship, Poland
Duplicate_Optimum Profesorskie Centrum Okulistyki Sp. z o.o. /ID# 240307
Gdansk, Pomeranian Voivodeship, Poland
Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 240248
Olsztyn, Warmian-Masurian Voivodeship, Poland
S. Fyodorov Eye Microsurgery Federal State Institution /ID# 240251
Novosibirsk, Novosibirsk Oblast, Russia
Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 240253
Omsk, Omsk Oblast, Russia
Singapore National Eye Centre /ID# 240224
Singapore, , Singapore
Pretoria Eye Institute - Private Practice /ID# 240223
Pretoria, Gauteng, South Africa
Asan Medical Center /ID# 240286
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 240335
Seoul, Seoul Teugbyeolsi, South Korea
Duplicate_Seoul National University Hospital /ID# 240262
Seoul, , South Korea
Hospital Universitario Reina Sofia /ID# 240322
Córdoba, Cordoba, Spain
Hospital Clinico San Carlos /ID# 240303
Madrid, , Spain
Hospital Universitario Virgen Macarena /ID# 240325
Seville, , Spain
Maharaj Nakorn Chiang Mai Hospital /ID# 240194
Chiang Mai, , Thailand
Thammasat University Hospital /ID# 240231
Pathum Thani, , Thailand
Eskisehir Osmangazi University Medical School /ID# 240225
Eskişehir, , Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240296
Istanbul, , Turkey (Türkiye)
Addenbrookes Hospital /ID# 240351
Cambridge, Cambridgeshire, United Kingdom
Duplicate_NHS Lothian /ID# 240318
Edinburgh, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-003597-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-504601-36-00
Identifier Type: OTHER
Identifier Source: secondary_id
1698-302-007
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.