Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
Launched by ABBVIE · Mar 25, 2019
Trial Information
Current as of September 12, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This is an extension study looking at the long-term safety and how well Bimatoprost SR, an eye implant that slowly releases medicine to lower eye pressure, works in people with open-angle glaucoma or ocular hypertension. It is for adults who already took part in earlier Bimatoprost SR trials (or completed the ARGOS study) and who have no ongoing safety concerns. The main goal is to see how long the treatment effect lasts—about two years—and how often people have treatment-related side effects. The study is not a new randomized comparison; some participants’ eyes may get another implant during the trial, while others will continue with the standard eye-care approach determined by their doctor.
If you’re eligible, you’ll be adults 18 or older who previously completed the lead-in trials and received Bimatoprost SR, or completed ARGOS with no safety issues. Exclusions include pregnancy or breastfeeding, plans for pregnancy, participation in another investigational trial, or certain eye surgeries in the past. The trial is ongoing at many sites around the world, with about 600 participants, and is sponsored by AbbVie. Participants will have safety and eye pressure checks over roughly two years, and doctors will record any adverse events to understand how common they are and how they relate to the treatment. Additional information about data sharing is available if you’re interested.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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.
- • Concurrent or anticipated enrollment in another investigational drug or device study during the present study.
- • Any condition which would preclude the participant's ability to comply with study requirements, including completion of 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.
- • 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.
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Dothan, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Prescott, Arizona, United States
Sun City, Arizona, United States
Irvine, California, United States
La Jolla, California, United States
Newport Beach, California, United States
Rancho Cordova, California, United States
Redding, California, United States
Sacramento, California, United States
San Francisco, California, United States
Torrance, California, United States
Coral Springs, Florida, United States
Crystal River, Florida, United States
Delray Beach, Florida, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Tamarac, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Roswell, Georgia, United States
Bedford Park, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Winchester, Massachusetts, United States
Fraser, Michigan, United States
Saint Louis, Missouri, United States
Newark, New Jersey, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Oceanside, New York, United States
Rochester, New York, United States
Slingerlands, New York, United States
Asheville, North Carolina, United States
Belmont, North Carolina, United States
Elizabeth City, North Carolina, United States
Winston Salem, North Carolina, United States
Fargo, North Dakota, United States
Portland, Oregon, United States
Cranberry Township, Pennsylvania, United States
Memphis, Tennessee, United States
Smyrna, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Mission, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Falls Church, Virginia, United States
Lynchburg, Virginia, United States
Roanoke, Virginia, United States
Caba, Buenos Aires, Argentina
Mar Del Plata, Buenos Aires, Argentina
Pilar, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Mendoza, Argentina
Leuven, Vlaams Brabant, Belgium
Goiania, Goias, Brazil
Campinas, Sao Paulo, Brazil
Osasco, Sao Paulo, Brazil
Campo Grande, Brazil
Sao Paulo, Brazil
Halifax, Nova Scotia, Canada
Mississauga, Ontario, Canada
Medellin, Antioquia, Colombia
Bogota, Distrito Capital De Bogota, Colombia
Floridablanca, Santander, Colombia
Pardubice, Czechia
Glostrup, Hovedstaden, Denmark
Cairo, Egypt
Cairo, Egypt
Nice Cedex 1, Provence Alpes Cote D Azur, France
Bordeaux, France
Ecully, France
Dusseldorf, Nordrhein Westfalen, Germany
Magdeburg, Germany
Hong Kong, Hong Kong
Tel Aviv Yafo, Tel Aviv, Israel
Haifa, Israel
Haifa, Israel
Haifa, Israel
Perugia, Umbria, Italy
Catania, Italy
Chieti, Italy
Pisa, Italy
Seoul, Korea, Republic Of
Seoul, Korea, Republic Of
Seoul, Korea, Republic Of
Wellington, New Zealand
Lima, Peru
Makati City, Philippines
Makati City, Philippines
Makati City, Philippines
Gdansk, Pomorskie, Poland
Bydgoszcz, Poland
Lublin, Poland
Olsztyn, Poland
Novosibirsk, Russian Federation
Omsk, Russian Federation
Singapore, Singapore
Pretoria, Gauteng, South Africa
Cordoba, Spain
Madrid, Spain
Sevilla, Spain
Chiang Mai, Thailand
Pathumthani, Thailand
Eskisehir, Turkey
Istanbul, Turkey
Istanbul, Turkey
Cambridge, United Kingdom
Edinburgh, United Kingdom
London, United Kingdom
Culver City, California, United States
Pasadena, California, United States
Petaluma, California, United States
Colorado Springs, Colorado, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Elmhurst, Illinois, United States
Chesterfield, Missouri, United States
Dover, New Jersey, United States
Livingston, New Jersey, United States
Bronx, New York, United States
Oklahoma City, Oklahoma, United States
Nashville, Tennessee, United States
Bucaramanga, Santander, Colombia
Haifa, H Efa, Israel
Haifa, H Efa, Israel
Haifa, H Efa, Israel
Naharia, Hatsafon, Israel
Tel Aviv, Tel Aviv, Israel
Gdansk, Pomorskie, Poland
Olsztyn, Poland
Chicago, Illinois, United States
Bordeaux Cedex, Gironde, France
Pisa, Italy
St Louis, Missouri, United States
Chandler, Arizona, United States
Sun City, Arizona, United States
Irvine, California, United States
Rancho Cordova, California, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
New Orleans, Louisiana, United States
Winston Salem, North Carolina, United States
Nashville, Tennessee, United States
Campo Grande, Mato Grosso Do Sul, Brazil
Halifax, Nova Scotia, Canada
Cairo, Egypt
Bordeaux, Nouvelle Aquitaine, France
Ecully, Rhone, France
Catania, Italy
Chieti, Italy
Perugia, Italy
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Korea, Republic Of
Bydgoszcz, Kujawsko Pomorskie, Poland
Lublin, Lubelskie, Poland
Gdansk, Pomorskie, Poland
Olsztyn, Warminsko Mazurskie, Poland
Novosibirsk, Novosibirskaya Oblast, Russian Federation
Omsk, Omskaya Oblast, Russian Federation
Córdoba, Cordoba, Spain
Madrid, Spain
Cambridge, Cambridgeshire, United Kingdom
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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