18 Month Prospective Efficacy and Safety Study of Bimatoprost Intracameral Implant (DURYSTA)

NCT ID: NCT04647214

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-03

Study Completion Date

2024-07-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Open-angle Glaucoma Ocular Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bimatoprost intracameral implant (DURYSTA) 10μg

Patients with OAG or OHT who are scheduled for intracameral administration of a bimatoprost intracameral implant by their ophthalmologist.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Patient diagnosed with OAG or OHT who is scheduled to receive a bimatoprost intracameral implant in at least one eye.

Exclusion Criteria

\- 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ALLERGAN INC.

Role: STUDY_DIRECTOR

Allergan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Angeles Eye Institute /ID# 240368

Culver City, California, United States

Site Status

Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240364

La Jolla, California, United States

Site Status

American Institute of Research /ID# 247820

Los Angeles, California, United States

Site Status

North Bay Eye Associates Inc. /ID# 240362

Petaluma, California, United States

Site Status

Pacific Eye Associates /ID# 240536

San Francisco, California, United States

Site Status

Colorado Eye Institute /ID# 240798

Colorado Springs, Colorado, United States

Site Status

ICON Eye Care /ID# 240681

Grand Junction, Colorado, United States

Site Status

Eye Associates of Fort Meyers /ID# 244476

Fort Myers, Florida, United States

Site Status

MedEye Associates /ID# 240374

Miami, Florida, United States

Site Status

Center for Sight - Sarasota /ID# 244578

Sarasota, Florida, United States

Site Status

Newsom Eye & Laser Center /ID# 253287

Sebring, Florida, United States

Site Status

Dr. Andrew Gardner Logan, FL /ID# 240361

Tamarac, Florida, United States

Site Status

Your Eye Specialists /ID# 253286

Weston, Florida, United States

Site Status

Georgia Eye Partners /ID# 240061

Atlanta, Georgia, United States

Site Status

Kovach Eye Institute /ID# 244581

Elmhurst, Illinois, United States

Site Status

Stiles Eyecare Excellence /ID# 240376

Overland Park, Kansas, United States

Site Status

The Eye Care Institute /ID# 240367

Louisville, Kentucky, United States

Site Status

John Hopkins Wilmer Eye Institute /ID# 243701

Bethesda, Maryland, United States

Site Status

Midwest Vision Research Foundation at Pepose Vision Institute /ID# 240537

Chesterfield, Missouri, United States

Site Status

Wiles Eye Center /ID# 240808

Kansas City, Missouri, United States

Site Status

Ophthalmology Associates /ID# 240799

St Louis, Missouri, United States

Site Status

Eye Associates of North Jersey /ID# 244585

Dover, New Jersey, United States

Site Status

Hudson Eye /ID# 240805

Jersey City, New Jersey, United States

Site Status

Glaucoma Care Center /ID# 252021

Livingston, New Jersey, United States

Site Status

Burlington County Eye Physicians /ID# 244594

Willingboro, New Jersey, United States

Site Status

MaculaCare PLLC /ID# 244593

New York, New York, United States

Site Status

New York New Jersey Eye Institute /ID# 244590

Orangeburg, New York, United States

Site Status

New York Eye Surgery Associates, PLLC /ID# 244592

The Bronx, New York, United States

Site Status

Duke Eye Center /ID# 244478

Durham, North Carolina, United States

Site Status

Bergstrom Eye Research LLC /ID# 240363

Fargo, North Dakota, United States

Site Status

META Medical Research Institute, LLC /ID# 240800

Dayton, Ohio, United States

Site Status

Oklahoma Eye Surgeons /ID# 240373

Oklahoma City, Oklahoma, United States

Site Status

Scott and Christie and Associates /ID# 244574

Cranberry Township, Pennsylvania, United States

Site Status

Vanderbilt University Medical Center /ID# 244577

Nashville, Tennessee, United States

Site Status

Glaucoma Associates of Texas /ID# 240682

Dallas, Texas, United States

Site Status

Glaucoma Associates of Texas /ID# 253289

Dallas, Texas, United States

Site Status

El Paso Eye Surgeons, P.A. /ID# 240366

El Paso, Texas, United States

Site Status

DCT Shah Eye Research Institut /ID# 240375

Mission, Texas, United States

Site Status

The Eye Centers of Racine and Kenosha LTD /ID# 240059

Racine, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39946034 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MED-MA-EYE-0648

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.