NCT03891446CompletedPhase 3
Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in Patients With Open Angle Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov · Last updated 15 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 455 (actual)
- First submitted
- 25 Mar 2019
- Start date
- 27 Mar 2019
- Primary completion date
- 19 Jun 2026
- Lead sponsor
- AbbVie
- Diseases
- Glaucoma, High blood pressure
- NCT number
- NCT03891446
- EU CT number
- 2023-504601-36-00
- EudraCT number
- 2018-003597-26
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 455
- From 27 Mar 2019 to the primary completion date, 19 Jun 2026
- 121 sites in 26 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent or anticipated enrollment in another investigational drug or device study during the present study.
- 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.
Other illness
- Any condition which would preclude the participant's ability to comply with study requirements, including completion of the study.
Other
- 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.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (121)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247 Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Clinica Privada de Ojos /ID# 240272 Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| Oftar Mendoza /ID# 240308 Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
| Hospital Universitario Austral /ID# 240331 Coordinator of this site? Confirm its status | Pilar | Argentina | Unknown status |
| Oftalmología Global /ID# 240244 Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Universitair Ziekenhuis Leuven /ID# 240312 Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Clinica De Oftalmologia Nova Campinas /ID# 240271 Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| Hospital de Olhos de Mato Grosso Do Sul /ID# 240276 Coordinator of this site? Confirm its status | Campo Grande | Brazil | Unknown status |
| Hospital Oftalmologico Medicina dos Olhos /ID# 240277 Coordinator of this site? Confirm its status | Osasco | Brazil | Unknown status |
| Hospital Sao Paulo /ID# 240278 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 240336 Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Ophthalmic Consultant Centres /ID# 240205 Coordinator of this site? Confirm its status | Mississauga | Canada | Unknown status |
| Fundacion Oftalmologica Nacional /ID# 240226 Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634 Coordinator of this site? Confirm its status | Bucaramanga | Colombia | Unknown status |
| Clinica de Oftalmologia Sandiego /ID# 240233 Coordinator of this site? Confirm its status | Medellín | Colombia | Unknown status |
| Ocni klinika Pardubice /ID# 240347 Coordinator of this site? Confirm its status | Pardubice | Czechia | Unknown status |
| Internationale Innovative Ophthalmochirurgie GbR (I.I.O.) Coordinator of this site? Confirm its status | Duesseldorf | Germany | Completed |
| Rigshospitalet Glostrup /ID# 240330 Coordinator of this site? Confirm its status | Glostrup Municipality | Denmark | Unknown status |
| Duplicate_Ain Shams University Hospital /ID# 240338 Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
| Bostan Diagnostic Eye Center /ID# 240268 Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Completed |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Pellegrin Hospital Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Pole Vision Val d'Ouest Coordinator of this site? Confirm its status | Écully | France | Completed |
| Addenbrookes Hospital /ID# 240351 Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Duplicate_NHS Lothian /ID# 240318 Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| The Chinese University of Hong Kong /ID# 240283 Coordinator of this site? Confirm its status | Hong Kong | Hong Kong | Unknown status |
| The Lady Davis Carmel Medical Center /ID# 240293 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Rambam Health Care Campus /ID# 240332 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Bnai Zion Medical Center /ID# 240297 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Galilee Medical Center /ID# 251967 Coordinator of this site? Confirm its status | Nahariya | Israel | Unknown status |
| Tel Aviv Sourasky Medical Center /ID# 240311 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| AOU Policlinico G. Rodolico - San Marco /ID# 240305 Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| ASL 2 Abruzzo Lanciano-Vasto-Chieti /ID# 240217 Coordinator of this site? Confirm its status | Chieti | Italy | Unknown status |
| Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 240310 Coordinator of this site? Confirm its status | Perugia | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Pisana /ID# 240301 Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Samsung Medical Center /ID# 240335 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center /ID# 240286 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Duplicate_Seoul National University Hospital /ID# 240262 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Capital Eye Specialists /ID# 240259 Coordinator of this site? Confirm its status | Wellington | New Zealand | Unknown status |
| Centro Oftalmologico Macula Diagnostico and Tratamiento /ID# 240269 Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Asian Eye Institute /ID# 240213 Coordinator of this site? Confirm its status | Makati City | Philippines | Unknown status |
| Asian Eye Institute /ID# 240214 Coordinator of this site? Confirm its status | Makati City | Philippines | Unknown status |
| Peregrine Eye and Laser Institute /ID# 240260 Coordinator of this site? Confirm its status | Makati City | Philippines | Unknown status |
| OFTALMIKA Sp. z o.o Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o. Coordinator of this site? Confirm its status | Olsztyn | Poland | Completed |
| S. Fyodorov Eye Microsurgery Federal State Institution /ID# 240251 Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 240253 Coordinator of this site? Confirm its status | Omsk | Russia | Unknown status |
| Singapore National Eye Centre /ID# 240224 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Maharaj Nakorn Chiang Mai Hospital /ID# 240194 Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| Thammasat University Hospital /ID# 240231 Coordinator of this site? Confirm its status | Pathum Thani | Thailand | Unknown status |
| Eye Associates of New Mexico /ID# 240216 Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Asheville Eye Associates /ID# 240202 Coordinator of this site? Confirm its status | Asheville | United States | Unknown status |
| Duplicate_Emory University /ID# 240328 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Keystone Research LTD /ID# 240185 Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Chicago Eye Specialists /ID# 240270 Coordinator of this site? Confirm its status | Bedford Park | United States | Unknown status |
| Arizona Eye Center - West Ray Road /ID# 240239 Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| Charlotte Eye Ear Nose And Throat Associates- Southpark /ID# 240339 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Midwest Vision Research Foundation at Pepose Vision Institute /ID# 250402 Coordinator of this site? Confirm its status | Chesterfield | United States | Unknown status |
| University of Illinois Hospital and Health Sciences System /ID# 250981 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Colorado Eye Institute /ID# 248910 Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Specialty Retina Center /ID# 240254 Coordinator of this site? Confirm its status | Coral Springs | United States | Unknown status |
| Scott and Christie and Associates /ID# 240189 Coordinator of this site? Confirm its status | Cranberry Township | United States | Unknown status |
| Nature Coast Clinical Research - Crystal River /ID# 240334 Coordinator of this site? Confirm its status | Crystal River | United States | Unknown status |
| Angeles Eye Institute /ID# 250397 Coordinator of this site? Confirm its status | Culver City | United States | Unknown status |
| Bruce Segal, MD /ID# 240292 Coordinator of this site? Confirm its status | Delray Beach | United States | Unknown status |
| Trinity Research Group /ID# 240190 Coordinator of this site? Confirm its status | Dothan | United States | Unknown status |
| Eye Associates of North Jersey /ID# 250445 Coordinator of this site? Confirm its status | Dover | United States | Unknown status |
| Albemarle Clinical Trials LLC /ID# 240219 Coordinator of this site? Confirm its status | Elizabeth City | United States | Unknown status |
| Kovach Eye Institute /ID# 250442 Coordinator of this site? Confirm its status | Elmhurst | United States | Unknown status |
| Emerson Clinical Research Institute - Falls Church /ID# 240274 Coordinator of this site? Confirm its status | Falls Church | United States | Unknown status |
| Bergstrom Eye Research LLC /ID# 240257 Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| Eye Associates of Fort Meyers /ID# 240218 Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Fraser Eye Center /ID# 240245 Coordinator of this site? Confirm its status | Fraser | United States | Unknown status |
| Houston Eye Associates /ID# 240340 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| IN Univ School of Medicine /ID# 240294 Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Duplicate_Lakeside Vision Center /ID# 240204 Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| Levenson Eye Associates- Riverside Park Place /ID# 240209 Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196 Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Glaucoma Care Center /ID# 250978 Coordinator of this site? Confirm its status | Livingston | United States | Unknown status |
| The Eye Care Institute /ID# 240289 Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Piedmont Eye Center /ID# 240187 Coordinator of this site? Confirm its status | Lynchburg | United States | Unknown status |
| Eye Specialty Group /ID# 240241 Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| MedEye Associates /ID# 240333 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| DCT Shah Eye Research Institut /ID# 240306 Coordinator of this site? Confirm its status | Mission | United States | Unknown status |
| Vanderbilt Eye Institute /ID# 252659 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 240181 Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Duplicate_Tulane University /ID# 240327 Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| The Eye Research Foundation /ID# 240186 Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Ophthalmic Consultants Long Island /ID# 240211 Coordinator of this site? Confirm its status | Oceanside | United States | Unknown status |
| Oklahoma Eye Surgeons /ID# 250430 Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| North Bay Eye Associates Inc. /ID# 248912 Coordinator of this site? Confirm its status | Petaluma | United States | Unknown status |
| Arizona Glaucoma Specialists /ID# 240212 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Plano Office /ID# 240243 Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Legacy Devers Eye Institute /ID# 240210 Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| M&M Eye Institute /ID# 240236 Coordinator of this site? Confirm its status | Prescott | United States | Unknown status |
| Duplicate_Martel Eye Medical Group /ID# 240291 Coordinator of this site? Confirm its status | Rancho Cordova | United States | Unknown status |
| The Clinical Trials Network (CTNx) /ID# 240284 Coordinator of this site? Confirm its status | Redding | United States | Unknown status |
| Vistar Eye Center /ID# 240198 Coordinator of this site? Confirm its status | Roanoke | United States | Unknown status |
| Rochester Ophthalmological Group PC /ID# 240290 Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Coastal Research Associates /ID# 240192 Coordinator of this site? Confirm its status | Roswell | United States | Unknown status |
| Sacramento Eye Consultants /ID# 240263 Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| San Antonio Eye Center /ID# 240238 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Medical Center Ophthalmology Associates /ID# 240208 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Eye associates /ID# 240265 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Pacific Eye Associates /ID# 240234 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Glaucoma associates/consultants of the capital region /ID# 240195 Coordinator of this site? Confirm its status | Slingerlands | United States | Unknown status |
| Advancing Vision Research /ID# 240288 Coordinator of this site? Confirm its status | Smyrna | United States | Unknown status |
| Tekwani Vision Center /ID# 240220 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Horizon Eye Specialists & Lasik Centers /ID# 240255 Coordinator of this site? Confirm its status | Sun City | United States | Unknown status |
| Logan Ophthalmic Research Inc. /ID# 240280 Coordinator of this site? Confirm its status | Tamarac | United States | Unknown status |
| International Research Center /ID# 240346 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| University of South Florida- Neuroscience Institute /ID# 250980 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Montefiore Hospital /ID# 240324 Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Wolstan & Goldberg Eye Associates /ID# 240221 Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
| Clinical Eye Research of Boston LLC /ID# 240203 Coordinator of this site? Confirm its status | Winchester | United States | Unknown status |
| Private Practice - Dr. James D. Branch /ID# 240188 Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| Pretoria Eye Institute - Private Practice /ID# 240223 Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
| Eskisehir Osmangazi University Medical School /ID# 240225 Coordinator of this site? Confirm its status | Eskişehir | Turkey (Türkiye) | Unknown status |
| Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240296 Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.