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NCT03850782 Clinical Trial

Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

Ocular Hypertension Clinical Trial

Official title:
A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03850782
Other study ID # 1698-301-007
Secondary ID 2018-002574-5220
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date February 28, 2019
Est. completion date August 9, 2025

Study information
Verified date February 2024
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 515
Est. completion date August 9, 2025
Est. primary completion date August 9, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bimatoprost (SR)
Study Eye: Cycles 1 - 3 administrations through the PRN treatment period. Fellow Eye: Standard of care or Bimatoprost SR.

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

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bulgaria,  Czechia,  Denmark,  Germany,  Hungary,  Ireland,  Italy,  New Zealand,  Poland,  Russian Federation,  South Africa,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Retreatment or rescue administered for IOP Treatment modality determined by investigator. Up to 48 months
Primary Number of patients experiencing a treatment emergent adverse event The number of patients who experienced one or more TEAE during the 48 month treatment period. Baseline up to 48 months
See also
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Completed NCT01157364 - Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension Phase 1/Phase 2
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Recruiting NCT02792803 - A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma Phase 4
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml Phase 4
Completed NCT02558374 - Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension Phase 3
Terminated NCT02801617 - Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension Phase 3
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
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Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT02246764 - Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02993445 - Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension N/A
Completed NCT01936389 - A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma Phase 2
Completed NCT02003547 - A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects Phase 1
Completed NCT01995136 - Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma Phase 4
Completed NCT01664039 - An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN® Phase 4
Completed NCT01693315 - Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma Phase 2
Active, not recruiting NCT01430923 - Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost N/A
Completed NCT01410188 - Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension Phase 1/Phase 2
Completed NCT01415401 - Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada Phase 4

External Links