18 Month Prospective Efficacy and Safety Study of Bimatoprost Intracameral Implant (DURYSTA)
ARGOS
ARGOS - A Phase IV, Prospective, 18-month Study to Assess the Effectiveness and Safety of Bimatoprost Intracameral Implant (DURYSTA) in US Clinical Practice
1 other identifier
observational
220
1 country
39
Brief Summary
Study to collect effectiveness and safety data after administration of a bimatoprost intracameral implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Typical duration for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2020
CompletedFirst Posted
Study publicly available on registry
November 30, 2020
CompletedStudy Start
First participant enrolled
March 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2024
CompletedAugust 3, 2025
July 1, 2025
3.4 years
November 23, 2020
July 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of treated eyes that did not receive additional Intraocular Pressure (IOP) -lowering intervention/therapy per standard medical care
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Baseline to Month 6
Secondary Outcomes (26)
Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care
Baseline to Month 4
Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care
Baseline to Month 9
Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care
Baseline to Month 12
Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care
Baseline to Month 18
Time from bimatoprost intracameral implant to first additional IOP-lowering intervention/therapy
Baseline to Month 18
- +21 more secondary outcomes
Study Arms (1)
Bimatoprost intracameral implant (DURYSTA) 10μg
Patients with OAG or OHT who are scheduled for intracameral administration of a bimatoprost intracameral implant by their ophthalmologist.
Eligibility Criteria
The study population will include US patients with OAG or OHT who are scheduled for administration of a bimatoprost intracameral implant by their ophthalmologist.
You may qualify if:
- \- Patient diagnosed with OAG or OHT who is scheduled to receive a bimatoprost intracameral implant in at least one eye.
You may not qualify if:
- \- A history of any of the following ocular surgeries in the eye due to receive a bimatoprost intracameral implant:Ahmed Glaucoma Valve, Baerveldt shunt, Ex-Press glaucoma shunt implantation, Molteno shunt, Trabeculectomy, Vitrectomy, retinal surgery, CyPass Micro-Stent or Anterior Chamber Intraocular Lens (AC IOL) placement.
- Concurrent or anticipated enrollment in an interventional clinical trial involving either an investigational medicinal product or medical device.
- Previous enrollment in another Allergan bimatoprost intracameral implant study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (39)
Angeles Eye Institute /ID# 240368
Culver City, California, 90232, United States
Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240364
La Jolla, California, 92093, United States
American Institute of Research /ID# 247820
Los Angeles, California, 90027, United States
North Bay Eye Associates Inc. /ID# 240362
Petaluma, California, 94954-2387, United States
Pacific Eye Associates /ID# 240536
San Francisco, California, 94115, United States
Colorado Eye Institute /ID# 240798
Colorado Springs, Colorado, 80924-7003, United States
ICON Eye Care /ID# 240681
Grand Junction, Colorado, 81501-8180, United States
Eye Associates of Fort Meyers /ID# 244476
Fort Myers, Florida, 33901, United States
MedEye Associates /ID# 240374
Miami, Florida, 33143, United States
Center for Sight - Sarasota /ID# 244578
Sarasota, Florida, 34239, United States
Newsom Eye & Laser Center /ID# 253287
Sebring, Florida, 33870, United States
Dr. Andrew Gardner Logan, FL /ID# 240361
Tamarac, Florida, 33321, United States
Your Eye Specialists /ID# 253286
Weston, Florida, 33326, United States
Georgia Eye Partners /ID# 240061
Atlanta, Georgia, 30342, United States
Kovach Eye Institute /ID# 244581
Elmhurst, Illinois, 60126-2821, United States
Stiles Eyecare Excellence /ID# 240376
Overland Park, Kansas, 66213, United States
The Eye Care Institute /ID# 240367
Louisville, Kentucky, 40206, United States
John Hopkins Wilmer Eye Institute /ID# 243701
Bethesda, Maryland, 20817-1805, United States
Midwest Vision Research Foundation at Pepose Vision Institute /ID# 240537
Chesterfield, Missouri, 63017, United States
Wiles Eye Center /ID# 240808
Kansas City, Missouri, 64118-4390, United States
Ophthalmology Associates /ID# 240799
St Louis, Missouri, 63131, United States
Eye Associates of North Jersey /ID# 244585
Dover, New Jersey, 07801-1629, United States
Hudson Eye /ID# 240805
Jersey City, New Jersey, 07306-2929, United States
Glaucoma Care Center /ID# 252021
Livingston, New Jersey, 07039, United States
Burlington County Eye Physicians /ID# 244594
Willingboro, New Jersey, 08046-1109, United States
MaculaCare PLLC /ID# 244593
New York, New York, 10021, United States
New York New Jersey Eye Institute /ID# 244590
Orangeburg, New York, 10962-2185, United States
New York Eye Surgery Associates, PLLC /ID# 244592
The Bronx, New York, 10469, United States
Duke Eye Center /ID# 244478
Durham, North Carolina, 27705, United States
Bergstrom Eye Research LLC /ID# 240363
Fargo, North Dakota, 58103, United States
META Medical Research Institute, LLC /ID# 240800
Dayton, Ohio, 45432-1400, United States
Oklahoma Eye Surgeons /ID# 240373
Oklahoma City, Oklahoma, 73112, United States
Scott and Christie and Associates /ID# 244574
Cranberry Township, Pennsylvania, 16066, United States
Vanderbilt University Medical Center /ID# 244577
Nashville, Tennessee, 37232-0011, United States
Glaucoma Associates of Texas /ID# 240682
Dallas, Texas, 75231, United States
Glaucoma Associates of Texas /ID# 253289
Dallas, Texas, 75231, United States
El Paso Eye Surgeons, P.A. /ID# 240366
El Paso, Texas, 79902, United States
DCT Shah Eye Research Institut /ID# 240375
Mission, Texas, 78572, United States
The Eye Centers of Racine and Kenosha LTD /ID# 240059
Racine, Wisconsin, 53405, United States
Related Publications (1)
Mann E, Kammer JA, Sawhney G, An J, Werts EC, Vera V, Rivas M, Lai H, Sonparote S, Craven ER. Prospective 18-Month Study of Bimatoprost Intracameral Implant in Patients with Open-Angle Glaucoma or Ocular Hypertension in US Clinical Practice. Drugs. 2025 Mar;85(3):397-414. doi: 10.1007/s40265-025-02157-1. Epub 2025 Feb 13.
PMID: 39946034DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ALLERGAN INC.
Allergan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2020
First Posted
November 30, 2020
Study Start
March 3, 2021
Primary Completion
July 12, 2024
Study Completion
July 12, 2024
Last Updated
August 3, 2025
Record last verified: 2025-07