ClinicalTrials.gg
CompletedNCT04647214ARGOSUpdated Aug 3, 2025

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

An observational study in Open-angle Glaucoma and Ocular Hypertension, sponsored by Allergan. Completed at 39 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-03.

Sponsored by Allergan (part of AbbVie) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
220
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Open-angle Glaucoma
  • Ocular Hypertension
03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's enrollment of 220 is above the median of 101 across 184 observational studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.

First submitted after Allergan became part of AbbVie.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will include US patients with OAG or OHT who are scheduled for administration of a bimatoprost intracameral implant by their ophthalmologist.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 medicinal product or medical device.
  • Previous enrollment in another Allergan bimatoprost intracameral implant study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
220 participants (actual)

Groups and cohorts

  • Bimatoprost intracameral implant (DURYSTA) 10μg

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

06

What researchers measure

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.

    Time frame: Baseline to Month 6

Secondary outcomes

  1. Proportion of treated eyes not receiving additional 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.

    Time frame: Baseline to Month 4

  2. Proportion of treated eyes not receiving additional 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.

    Time frame: Baseline to Month 9

  3. Proportion of treated eyes not receiving additional 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.

    Time frame: Baseline to Month 12

  4. Proportion of treated eyes not receiving additional 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.

    Time frame: Baseline to Month 18

  5. Time from bimatoprost intracameral implant to first additional IOP-lowering intervention/therapy

    Time to first IOP-lowering intervention is defined as the time between treatment and IOP-lowering intervention.

    Time frame: Baseline to Month 18

  6. Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy

    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.

    Time frame: Baseline to Month 4

  7. Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy

    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.

    Time frame: Baseline to Month 6

  8. Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy

    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.

    Time frame: Baseline to Month 9

  9. Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy

    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.

    Time frame: Baseline to Month 12

  10. Proportion of treated eyes achieving predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy

    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.

    Time frame: Baseline to Month 18

  11. Mean reduction in the number of topical IOP-lowering medications

    A numerical count by class of drug of topical IOP lowering medications being taken.

    Time frame: Baseline to Month 4

  12. Mean reduction in the number of topical IOP-lowering medications

    A numerical count by class of drug of topical IOP lowering medications being taken.

    Time frame: Baseline to Month 6

  13. Mean reduction in the number of topical IOP-lowering medications

    A numerical count by class of drug of topical IOP lowering medications being taken.

    Time frame: Baseline to Month 9

  14. Mean reduction in the number of topical IOP-lowering medications

    A numerical count by class of drug of topical IOP lowering medications being taken.

    Time frame: Baseline to Month 12

  15. Mean reduction in the number of topical IOP-lowering medications

    A numerical count by class of drug of topical IOP lowering medications being taken.

    Time frame: Baseline to Month 18

  16. Proportion of treated eyes achieving complete success

    Complete success is defined as treated eyes with IOP \<=18 mm Hg without any additional IOP lowering interventions/therapies after administration of the bimatoprost intracameral implant.

    Time frame: Baseline to Month 4

  17. Proportion of treated eyes achieving complete success

    Complete success is defined as treated eyes with IOP \<=18 mm Hg without any additional IOP lowering interventions/therapies after administration of the bimatoprost intracameral implant.

    Time frame: Baseline to Month 6

  18. Proportion of treated eyes achieving complete success

    Complete success is defined as treated eyes with IOP \<=18 mm Hg without any additional IOP lowering interventions/therapies after administration of the bimatoprost intracameral implant.

    Time frame: Baseline to Month 9

  19. Proportion of treated eyes achieving complete success

    Complete success is defined as treated eyes with IOP \<=18 mm Hg without any additional IOP lowering interventions/therapies after administration of the bimatoprost intracameral implant.

    Time frame: Baseline to Month 12

  20. Proportion of treated eyes achieving complete success

    Complete success is defined as treated eyes with IOP \<=18 mm Hg without any additional IOP lowering interventions/therapies after administration of the bimatoprost intracameral implant.

    Time frame: Baseline to Month 18

  21. Proportion of treated eyes achieving qualified success

    Partial success is defined as treated eyes with IOP \<=18 mm Hg with no Secondary Surgical Intervention (SSI) for glaucoma, while staying on the same or fewer topical IOP-lowering medications than baseline and or Selective Laser Trabeculoplasty (SLT), Argon Laser Trabeculoplasty (ALT) or MicroPulse Laser Trabeculoplasty (MLT).

    Time frame: Baseline to Month 4

  22. Proportion of treated eyes achieving qualified success

    Partial success is defined as treated eyes with IOP \<=18 mm Hg with no Secondary Surgical Intervention (SSI) for glaucoma, while staying on the same or fewer topical IOP-lowering medications than baseline and or Selective Laser Trabeculoplasty (SLT), Argon Laser Trabeculoplasty (ALT) or MicroPulse Laser Trabeculoplasty (MLT).

    Time frame: Baseline to Month 6

  23. Proportion of treated eyes achieving qualified success

    Partial success is defined as treated eyes with IOP \<=18 mm Hg with no Secondary Surgical Intervention (SSI) for glaucoma, while staying on the same or fewer topical IOP-lowering medications than baseline and or Selective Laser Trabeculoplasty (SLT), Argon Laser Trabeculoplasty (ALT) or MicroPulse Laser Trabeculoplasty (MLT).

    Time frame: Baseline to Month 9

  24. Proportion of treated eyes achieving qualified success

    Partial success is defined as treated eyes with IOP \<=18 mm Hg with no Secondary Surgical Intervention (SSI) for glaucoma, while staying on the same or fewer topical IOP-lowering medications than baseline and or Selective Laser Trabeculoplasty (SLT), Argon Laser Trabeculoplasty (ALT) or MicroPulse Laser Trabeculoplasty (MLT).

    Time frame: Baseline to Month 12

  25. Proportion of treated eyes achieving qualified success

    Partial success is defined as treated eyes with IOP ≤18 mm Hg with no Secondary Surgical Intervention (SSI) for glaucoma, while staying on the same or fewer topical IOP-lowering medications than baseline and or Selective Laser Trabeculoplasty (SLT), Argon Laser Trabeculoplasty (ALT) or MicroPulse Laser Trabeculoplasty (MLT).

    Time frame: Baseline to Month 18

  26. Number of participants experiencing treatment emergent adverse events

    Time frame: Baseline to Month 18

07

Study locations

39 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 39946034 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2021 to primary completion in Jul 2024, 40 months.

Of 53 observational studies under Glaucoma, Open-Angle, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12. This study's 40 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2020
First posted
Nov 30, 2020
StartActual
Mar 3, 2021
Primary completionActual
Jul 12, 2024
CompletionActual
Jul 12, 2024
Last update
Aug 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04647214
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Nov 30, 2020
Start date
Mar 3, 2021
Primary completion
Jul 12, 2024
Completion
Jul 12, 2024
Last update
Aug 3, 2025

Study contacts

ALLERGAN INC.
study director · Allergan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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