Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

Completed · Phase 3

Conditions studied: Open-Angle Glaucoma, Ocular Hypertension

In brief

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.

Key facts

Study ID

NCT03891446

Run by

AbbVie

People needed

455

Starts

2019-03-27

Expected to finish

2026-06-19

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Eye Center - West Ray Road /ID# 240239 — Chandler, Arizona, United States
• Arizona Glaucoma Specialists /ID# 240212 — Phoenix, Arizona, United States
• M&M Eye Institute /ID# 240236 — Prescott, Arizona, United States
• Horizon Eye Specialists & Lasik Centers /ID# 240255 — Sun City, Arizona, United States
• Angeles Eye Institute /ID# 250397 — Culver City, California, United States
• Duplicate_Lakeside Vision Center /ID# 240204 — Irvine, California, United States
• Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196 — La Jolla, California, United States
• The Eye Research Foundation /ID# 240186 — Newport Beach, California, United States
• North Bay Eye Associates Inc. /ID# 248912 — Petaluma, California, United States
• Duplicate_Martel Eye Medical Group /ID# 240291 — Rancho Cordova, California, United States
• The Clinical Trials Network (CTNx) /ID# 240284 — Redding, California, United States
• Sacramento Eye Consultants /ID# 240263 — Sacramento, California, United States
• Pacific Eye Associates /ID# 240234 — San Francisco, California, United States
• Wolstan & Goldberg Eye Associates /ID# 240221 — Torrance, California, United States
• Colorado Eye Institute /ID# 248910 — Colorado Springs, Colorado, United States
• Specialty Retina Center /ID# 240254 — Coral Springs, Florida, United States
• Nature Coast Clinical Research - Crystal River /ID# 240334 — Crystal River, Florida, United States
• Bruce Segal, MD /ID# 240292 — Delray Beach, Florida, United States
• Eye Associates of Fort Meyers /ID# 240218 — Fort Myers, Florida, United States
• Levenson Eye Associates- Riverside Park Place /ID# 240209 — Jacksonville, Florida, United States
• MedEye Associates /ID# 240333 — Miami, Florida, United States
• Logan Ophthalmic Research Inc. /ID# 240280 — Tamarac, Florida, United States
• International Research Center /ID# 240346 — Tampa, Florida, United States
• University of South Florida- Neuroscience Institute /ID# 250980 — Tampa, Florida, United States
• Trinity Research Group /ID# 240190 — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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