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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
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

Full criteria on ClinicalTrials.gov

Sites (121)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247
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CABAArgentinaUnknown status
Clinica Privada de Ojos /ID# 240272
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Mar del PlataArgentinaUnknown status
Oftar Mendoza /ID# 240308
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MendozaArgentinaUnknown status
Hospital Universitario Austral /ID# 240331
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PilarArgentinaUnknown status
Oftalmología Global /ID# 240244
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RosarioArgentinaUnknown status
Universitair Ziekenhuis Leuven /ID# 240312
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LeuvenBelgiumUnknown status
Clinica De Oftalmologia Nova Campinas /ID# 240271
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CampinasBrazilUnknown status
Hospital de Olhos de Mato Grosso Do Sul /ID# 240276
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Campo GrandeBrazilUnknown status
Hospital Oftalmologico Medicina dos Olhos /ID# 240277
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OsascoBrazilUnknown status
Hospital Sao Paulo /ID# 240278
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São PauloBrazilUnknown status
Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 240336
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HalifaxCanadaUnknown status
Ophthalmic Consultant Centres /ID# 240205
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MississaugaCanadaUnknown status
Fundacion Oftalmologica Nacional /ID# 240226
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BogotáColombiaUnknown status
Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634
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BucaramangaColombiaUnknown status
Clinica de Oftalmologia Sandiego /ID# 240233
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MedellínColombiaUnknown status
Ocni klinika Pardubice /ID# 240347
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PardubiceCzechiaUnknown status
Internationale Innovative Ophthalmochirurgie GbR (I.I.O.)
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DuesseldorfGermanyCompleted
Rigshospitalet Glostrup /ID# 240330
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Glostrup MunicipalityDenmarkUnknown status
Duplicate_Ain Shams University Hospital /ID# 240338
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CairoEgyptUnknown status
Bostan Diagnostic Eye Center /ID# 240268
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CairoEgyptUnknown status
Hospital Universitario Reina Sofia
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CórdobaSpainCompleted
Hospital Universitario Virgen De La Macarena
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SevillaSpainCompleted
Pellegrin Hospital
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BordeauxFranceCompleted
Pole Vision Val d'Ouest
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ÉcullyFranceCompleted
Addenbrookes Hospital /ID# 240351
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CambridgeUnited KingdomUnknown status
Duplicate_NHS Lothian /ID# 240318
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EdinburghUnited KingdomUnknown status
The Chinese University of Hong Kong /ID# 240283
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Hong KongHong KongUnknown status
The Lady Davis Carmel Medical Center /ID# 240293
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HaifaIsraelUnknown status
Rambam Health Care Campus /ID# 240332
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HaifaIsraelUnknown status
Bnai Zion Medical Center /ID# 240297
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HaifaIsraelUnknown status
Galilee Medical Center /ID# 251967
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NahariyaIsraelUnknown status
Tel Aviv Sourasky Medical Center /ID# 240311
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Tel AvivIsraelUnknown status
AOU Policlinico G. Rodolico - San Marco /ID# 240305
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CataniaItalyUnknown status
ASL 2 Abruzzo Lanciano-Vasto-Chieti /ID# 240217
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ChietiItalyUnknown status
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 240310
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PerugiaItalyUnknown status
Azienda Ospedaliero Universitaria Pisana /ID# 240301
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PisaItalyUnknown status
Samsung Medical Center /ID# 240335
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SeoulSouth KoreaUnknown status
Asan Medical Center /ID# 240286
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SeoulSouth KoreaUnknown status
Duplicate_Seoul National University Hospital /ID# 240262
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SeoulSouth KoreaUnknown status
Capital Eye Specialists /ID# 240259
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WellingtonNew ZealandUnknown status
Centro Oftalmologico Macula Diagnostico and Tratamiento /ID# 240269
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LimaPeruUnknown status
Asian Eye Institute /ID# 240213
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Makati CityPhilippinesUnknown status
Asian Eye Institute /ID# 240214
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Makati CityPhilippinesUnknown status
Peregrine Eye and Laser Institute /ID# 240260
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Makati CityPhilippinesUnknown status
OFTALMIKA Sp. z o.o
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BydgoszczPolandCompleted
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
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LublinPolandCompleted
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
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OlsztynPolandCompleted
S. Fyodorov Eye Microsurgery Federal State Institution /ID# 240251
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NovosibirskRussiaUnknown status
Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 240253
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OmskRussiaUnknown status
Singapore National Eye Centre /ID# 240224
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SingaporeSingaporeUnknown status
Maharaj Nakorn Chiang Mai Hospital /ID# 240194
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Chiang MaiThailandUnknown status
Thammasat University Hospital /ID# 240231
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Pathum ThaniThailandUnknown status
Eye Associates of New Mexico /ID# 240216
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AlbuquerqueUnited StatesUnknown status
Asheville Eye Associates /ID# 240202
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AshevilleUnited StatesUnknown status
Duplicate_Emory University /ID# 240328
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AtlantaUnited StatesUnknown status
Keystone Research LTD /ID# 240185
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AustinUnited StatesUnknown status
Chicago Eye Specialists /ID# 240270
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Bedford ParkUnited StatesUnknown status
Arizona Eye Center - West Ray Road /ID# 240239
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ChandlerUnited StatesUnknown status
Charlotte Eye Ear Nose And Throat Associates- Southpark /ID# 240339
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CharlotteUnited StatesUnknown status
Midwest Vision Research Foundation at Pepose Vision Institute /ID# 250402
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ChesterfieldUnited StatesUnknown status
University of Illinois Hospital and Health Sciences System /ID# 250981
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ChicagoUnited StatesUnknown status
Colorado Eye Institute /ID# 248910
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Colorado SpringsUnited StatesUnknown status
Specialty Retina Center /ID# 240254
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Coral SpringsUnited StatesUnknown status
Scott and Christie and Associates /ID# 240189
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Cranberry TownshipUnited StatesUnknown status
Nature Coast Clinical Research - Crystal River /ID# 240334
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Crystal RiverUnited StatesUnknown status
Angeles Eye Institute /ID# 250397
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Culver CityUnited StatesUnknown status
Bruce Segal, MD /ID# 240292
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Delray BeachUnited StatesUnknown status
Trinity Research Group /ID# 240190
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DothanUnited StatesUnknown status
Eye Associates of North Jersey /ID# 250445
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DoverUnited StatesUnknown status
Albemarle Clinical Trials LLC /ID# 240219
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Elizabeth CityUnited StatesUnknown status
Kovach Eye Institute /ID# 250442
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ElmhurstUnited StatesUnknown status
Emerson Clinical Research Institute - Falls Church /ID# 240274
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Falls ChurchUnited StatesUnknown status
Bergstrom Eye Research LLC /ID# 240257
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FargoUnited StatesUnknown status
Eye Associates of Fort Meyers /ID# 240218
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Fort MyersUnited StatesUnknown status
Fraser Eye Center /ID# 240245
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FraserUnited StatesUnknown status
Houston Eye Associates /ID# 240340
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HoustonUnited StatesUnknown status
IN Univ School of Medicine /ID# 240294
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IndianapolisUnited StatesUnknown status
Duplicate_Lakeside Vision Center /ID# 240204
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IrvineUnited StatesUnknown status
Levenson Eye Associates- Riverside Park Place /ID# 240209
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JacksonvilleUnited StatesUnknown status
Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196
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La JollaUnited StatesUnknown status
Glaucoma Care Center /ID# 250978
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LivingstonUnited StatesUnknown status
The Eye Care Institute /ID# 240289
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LouisvilleUnited StatesUnknown status
Piedmont Eye Center /ID# 240187
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LynchburgUnited StatesUnknown status
Eye Specialty Group /ID# 240241
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MemphisUnited StatesUnknown status
MedEye Associates /ID# 240333
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MiamiUnited StatesUnknown status
DCT Shah Eye Research Institut /ID# 240306
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MissionUnited StatesUnknown status
Vanderbilt Eye Institute /ID# 252659
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NashvilleUnited StatesUnknown status
Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 240181
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NewarkUnited StatesUnknown status
Duplicate_Tulane University /ID# 240327
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New OrleansUnited StatesUnknown status
The Eye Research Foundation /ID# 240186
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Newport BeachUnited StatesUnknown status
Ophthalmic Consultants Long Island /ID# 240211
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OceansideUnited StatesUnknown status
Oklahoma Eye Surgeons /ID# 250430
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Oklahoma CityUnited StatesUnknown status
North Bay Eye Associates Inc. /ID# 248912
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PetalumaUnited StatesUnknown status
Arizona Glaucoma Specialists /ID# 240212
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PhoenixUnited StatesUnknown status
Plano Office /ID# 240243
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PlanoUnited StatesUnknown status
Legacy Devers Eye Institute /ID# 240210
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PortlandUnited StatesUnknown status
M&M Eye Institute /ID# 240236
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PrescottUnited StatesUnknown status
Duplicate_Martel Eye Medical Group /ID# 240291
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Rancho CordovaUnited StatesUnknown status
The Clinical Trials Network (CTNx) /ID# 240284
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ReddingUnited StatesUnknown status
Vistar Eye Center /ID# 240198
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RoanokeUnited StatesUnknown status
Rochester Ophthalmological Group PC /ID# 240290
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RochesterUnited StatesUnknown status
Coastal Research Associates /ID# 240192
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RoswellUnited StatesUnknown status
Sacramento Eye Consultants /ID# 240263
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SacramentoUnited StatesUnknown status
San Antonio Eye Center /ID# 240238
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San AntonioUnited StatesUnknown status
Medical Center Ophthalmology Associates /ID# 240208
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San AntonioUnited StatesUnknown status
Eye associates /ID# 240265
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San AntonioUnited StatesUnknown status
Pacific Eye Associates /ID# 240234
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San FranciscoUnited StatesUnknown status
Glaucoma associates/consultants of the capital region /ID# 240195
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SlingerlandsUnited StatesUnknown status
Advancing Vision Research /ID# 240288
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SmyrnaUnited StatesUnknown status
Tekwani Vision Center /ID# 240220
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St LouisUnited StatesUnknown status
Horizon Eye Specialists & Lasik Centers /ID# 240255
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Sun CityUnited StatesUnknown status
Logan Ophthalmic Research Inc. /ID# 240280
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TamaracUnited StatesUnknown status
International Research Center /ID# 240346
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TampaUnited StatesUnknown status
University of South Florida- Neuroscience Institute /ID# 250980
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TampaUnited StatesUnknown status
Montefiore Hospital /ID# 240324
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The BronxUnited StatesUnknown status
Wolstan & Goldberg Eye Associates /ID# 240221
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TorranceUnited StatesUnknown status
Clinical Eye Research of Boston LLC /ID# 240203
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WinchesterUnited StatesUnknown status
Private Practice - Dr. James D. Branch /ID# 240188
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Winston-SalemUnited StatesUnknown status
Pretoria Eye Institute - Private Practice /ID# 240223
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PretoriaSouth AfricaUnknown status
Eskisehir Osmangazi University Medical School /ID# 240225
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EskişehirTurkey (Türkiye)Unknown status
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240296
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IstanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.