Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
- Conditions
- Open-Angle GlaucomaOcular Hypertension
- Interventions
- Registration Number
- NCT03850782
- Lead Sponsor
- AbbVie
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 515
- Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular pressure-lowering treatment.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bimatoprost SR - Dose A Bimatoprost (SR) 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. Bimatoprost SR - Dose B Bimatoprost (SR) 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.
- Primary Outcome Measures
Name Time Method Retreatment or rescue administered for IOP Up to 48 months Treatment modality determined by investigator.
Number of patients experiencing a treatment emergent adverse event Baseline up to 48 months The number of patients who experienced one or more TEAE during the 48 month treatment period.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (108)
Fraser Eye Center /ID# 235790
🇺🇸Fraser, Michigan, United States
AMA Eyes Research Institute /ID# 235542
🇺🇸Marysville, Ohio, United States
MHAT Hadzhi Dimitar /ID# 238248
🇧🇬Sliven, Bulgaria
Diagnostic consultative center Aleksandrovska /ID# 238105
🇧🇬Sofia, Bulgaria
Fondazione Bietti - Ospedale Britannico /ID# 235495
🇮🇹Rome, Italy
Drs Fine Hoffman & Sims LLC /ID# 235918
🇺🇸Eugene, Oregon, United States
Byers Eye Institute Stanford /ID# 235544
🇺🇸Palo Alto, California, United States
Horizon Eye Specialists & Lasik Centers /ID# 235240
🇺🇸Sun City, Arizona, United States
Universitatsklinikum Freiburg /ID# 238048
🇩🇪Freiburg im Breisgau, Baden-Wuerttemberg, Germany
Specialty Retina Center /ID# 236045
🇺🇸Coral Springs, Florida, United States
Augenzentrum Dr Hamacher /ID# 235537
🇩🇪Starnberg, Germany
Clinical Eye Research of Boston LLC /ID# 234966
🇺🇸Winchester, Massachusetts, United States
Oftalmología Global /ID# 239187
🇦🇷Rosario, Santa Fe, Argentina
UMHAT Sveti Georgi /ID# 237027
🇧🇬Plovdiv, Bulgaria
MHAT Dr. Bratan Shukerov /ID# 235498
🇧🇬Smolyan, Bulgaria
Foothill Eye Institute /ID# 235640
🇺🇸Pasadena, California, United States
Thomas Eye Group PC /ID# 235737
🇺🇸Sandy Springs, Georgia, United States
Ophthalmic Partners, PC /ID# 235741
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Alterman Modi & Wolter /ID# 235248
🇺🇸Poughkeepsie, New York, United States
Eye Specialty Group /ID# 235721
🇺🇸Memphis, Tennessee, United States
Piedmont Eye Center /ID# 234534
🇺🇸Lynchburg, Virginia, United States
Black Hills Regional Eye Institute /ID# 235075
🇺🇸Rapid City, South Dakota, United States
Hospital Italiano /ID# 235851
🇦🇷Buenos Aires, Argentina
Vance Thompson Vision /ID# 235072
🇺🇸Sioux Falls, South Dakota, United States
Centro Privado de Ojos /ID# 241283
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Cambridge University Hospitals NHS Foundation Trust /ID# 238255
🇬🇧Cambridge, United Kingdom
Eye Clinic University of Catania /ID# 235573
🇮🇹Catania, Italy
Liverpool University Hospitals NHS Foundation Trust /ID# 237095
🇬🇧Liverpool, United Kingdom
Liverpool University Hospitals NHS Foundation Trust /ID# 237321
🇬🇧Liverpool, United Kingdom
Centro oftalmologico Dr Charles /ID# 235881
🇦🇷Ciudad de Buenos Aires, Argentina
Specialized Hospital for Active Treatment in Ocular Diseases "Zrenie" /ID# 235500
🇧🇬Sofia, Bulgaria
St. Sofia Hospital /ID# 235525
🇧🇬Sofia, Bulgaria
Mid Essex Hospitals NHS Trust /ID# 237776
🇬🇧Chelmsford, United Kingdom
East Suffolk and North Essex NHS Foundation Trust /ID# 234657
🇬🇧Colchester, United Kingdom
Klinikum Dresden Friedrichstadt /ID# 235308
🇩🇪Dresden, Germany
S. Fyodorov Eye Microsurgery Federal State Institution /ID# 235984
🇷🇺Novosibirsk, Russian Federation
Ospedale Ss. Annunziata /ID# 236587
🇮🇹Chieti, Italy
University of Perugia /ID# 235811
🇮🇹Perugia, Italy
Capital Eye Specialists /ID# 236112
🇳🇿Wellington, New Zealand
Optimum Profesorskie Centrum Okulistyki Sp. z o.o. /ID# 237076
🇵🇱Gdansk, Pomorskie, Poland
Mid-Cheshire Hospitals NHS Trust /ID# 235418
🇬🇧Crewe, United Kingdom
Southern Eye Specialists /ID# 236080
🇳🇿Christchurch, Canterbury, New Zealand
Medical Center Julianow /ID# 235961
🇵🇱Lodz, Poland
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 237069
🇩🇪Kiel, Schleswig-Holstein, Germany
The Princess Alexandra NHS Trust /ID# 234433
🇬🇧Harlow, Essex, United Kingdom
Hospital Universitario Austral /ID# 237727
🇦🇷Pilar, Buenos Aires, Argentina
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 237383
🇭🇺Szombathely, Vas, Hungary
Medical center for eye healt Focus Ltd /ID# 235575
🇧🇬Sofia, Bulgaria
Gabinet Okulistyczny Edward Wylegala /ID# 235946
🇵🇱Katowice, Poland
Eye Surgery Associates /ID# 235873
🇦🇺East Melbourne, Victoria, Australia
Medical Center Oxycom Burgas /ID# 235580
🇧🇬Burgas, Bulgaria
Wojskowy Instytut Medyczny /ID# 237031
🇵🇱Warsaw, Mazowieckie, Poland
Oxford University Hospitals NHS Foundation Trust /ID# 237282
🇬🇧Oxford, Oxfordshire, United Kingdom
Budapest Retina Intezet /ID# 235950
🇭🇺Budapest, Hungary
Centrum Diagnostyki i Mikrochirurgii Oka - LENS sp. z o.o /ID# 235928
🇵🇱Olsztyn, Poland
Somerset Eye Specialist Medical & Surgical Centre /ID# 235540
🇿🇦Somerset West, Western Cape, South Africa
Fondazione IRCCS Policlinico /ID# 236909
🇮🇹Pavia, Italy
Sapienza University of Rome - Polo Pontino /ID# 237451
🇮🇹Terracina, Italy
Central Middlesex Hospital /ID# 236216
🇬🇧London, United Kingdom
King's College Hospital NHS Foundation Trust /ID# 237275
🇬🇧London, United Kingdom
York and Scarborough Teaching Hospitals NHS Foundation Trust /ID# 237683
🇬🇧York, United Kingdom
Atlantis Eye Care /ID# 235530
🇺🇸Huntington Beach, California, United States
Scott and Christie and Associates /ID# 234593
🇺🇸Cranberry Township, Pennsylvania, United States
Advancing Vision Research /ID# 236681
🇺🇸Smyrna, Tennessee, United States
Southern Utah Medical Research /ID# 235602
🇺🇸Saint George, Utah, United States
Consultorio Oftalmologico Dr. Fabian Lerner /ID# 235855
🇦🇷Caba, Buenos Aires, Argentina
Multiprofile Hospital for Active Treatment "Lozenetz" /ID# 244053
🇧🇬Sofiya, Sofia, Bulgaria
Oftar Mendoza /ID# 240535
🇦🇷Mendoza, Argentina
Pentagram Eye Hospital /Id# 235813
🇧🇬Sofia, Bulgaria
MHAT Trakia /ID# 238137
🇧🇬Stara Zagora, Bulgaria
Specialized Ophthalmological Hospital for Active Treatment - Varna /ID# 235962
🇧🇬Varna, Bulgaria
Medical center Orfey /ID# 237344
🇧🇬Stara Zagora, Bulgaria
Medical Center -Verea /ID# 235494
🇧🇬Stara Zagora, Bulgaria
Ocni klinika Pardubice /ID# 235944
🇨🇿Pardubice, Czechia
Fakultni nemocnice Kralovske Vinohrady /ID# 234323
🇨🇿Praha, Czechia
Rigshospitalet Glostrup /ID# 235743
🇩🇰Glostrup, Hovedstaden, Denmark
Vseobecna fakultni nemocnice v Praze /ID# 234422
🇨🇿Praha, Czechia
St. Franziskus-Hospital /ID# 237714
🇩🇪Muenster, Germany
Universitaetsmedizin Goettingen /ID# 237377
🇩🇪Goettingen, Germany
Asklepios Kinik Nord - Heidberg Augenklinik /ID# 235955
🇩🇪Hamburg, Germany
Dietrich-Bonhoeffer-Klinikum /ID# 235262
🇩🇪Neubrandenburg, Germany
Universitaetsmedizin Rostock /ID# 237263
🇩🇪Rostock, Germany
Jahn Ferenc Del-pesti Korhaz es Rendelointezet /ID# 237111
🇭🇺Budapest, Hungary
Gyongyosi Bugat Pal Korhaz /ID# 238144
🇭🇺Gyongyos, Heves, Hungary
Royal Victoria Eye and Ear Hospital /ID# 235546
🇮🇪Dublin, Ireland
Institute of Eye Surgery /ID# 235547
🇮🇪Waterford, Ireland
Pretoria Eye Institute - Private Practice /ID# 235658
🇿🇦Pretoria, Gauteng, South Africa
Norrlands University hospital /ID# 237553
🇸🇪Umea, Vasterbottens Lan, Sweden
Lakeside Vision Center /ID# 234970
🇺🇸Irvine, California, United States
Global Research Foundation /ID# 237350
🇺🇸Los Angeles, California, United States
The Eye Research Foundation /ID# 234521
🇺🇸Newport Beach, California, United States
Connecticut Eye Consultants P.C. /ID# 234981
🇺🇸Danbury, Connecticut, United States
Segal Drug Trials, Inc /ID# 235784
🇺🇸Delray Beach, Florida, United States
International Research Center /ID# 238050
🇺🇸Tampa, Florida, United States
Indiana University - Glick Eye Institute /ID# 235886
🇺🇸Indianapolis, Indiana, United States
Midwest Eye Institute /ID# 237876
🇺🇸Indianapolis, Indiana, United States
Tulane University /ID# 237632
🇺🇸New Orleans, Louisiana, United States
Ophthalmic Consultants of Boston /ID# 236534
🇺🇸Boston, Massachusetts, United States
University of Michigan, Kellogg Eye Center /ID# 236496
🇺🇸Ann Arbor, Michigan, United States
Silverstein Eye Centers /ID# 237881
🇺🇸Kansas City, Missouri, United States
The Ohio State University /ID# 236790
🇺🇸Columbus, Ohio, United States
Oklahoma Eye Surgeons /ID# 235849
🇺🇸Oklahoma City, Oklahoma, United States
Vanderbilt University Medical Center /ID# 237177
🇺🇸Nashville, Tennessee, United States
Moyes Eye Center PC /ID# 234989
🇺🇸Kansas City, Missouri, United States
ATX Clinical Trials Inc. dba Keystone Research /ID# 235868
🇺🇸Austin, Texas, United States
Medical Center Ophthalmology Associates - Keystone Research /ID# 235787
🇺🇸San Antonio, Texas, United States
Dean McGee Eye Institute /ID# 236823
🇺🇸Oklahoma City, Oklahoma, United States
University of Catanzaro /ID# 238066
🇮🇹Catanzaro, Calabria, Italy