Clinical trial NCT03850782: Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
Official title: A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: Open-Angle Glaucoma (OAG)
Ocular Hypertension (OHT)
Bimatoprost
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-02-22
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

- Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular pressure-lowering treatment.

Exclusion Criteria:

* 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.

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