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Completed

NCT Number: NCT04647214

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

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).

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Angeles Eye Institute /ID# 240368, Culver City, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Proportion of treated eyes that did not receive additional Intraocular Pressure (IOP) -lowering intervention/therapy per standard medical care

    Time frame: Baseline to Month 6

    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.

Secondary outcomes

  1. Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care

    Time frame: Baseline to Month 4

    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.

  2. Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care

    Time frame: Baseline to Month 9

    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.

  3. Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care

    Time frame: Baseline to Month 12

    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.

  4. Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care

    Time frame: Baseline to Month 18

    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.

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

    Time frame: Baseline to Month 18

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

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

    Time frame: Baseline to Month 4

    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.

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

    Time frame: Baseline to Month 6

    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.

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

    Time frame: Baseline to Month 9

    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.

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

    Time frame: Baseline to Month 12

    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.

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

    Time frame: Baseline to Month 18

    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.

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

    Time frame: Baseline to Month 4

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

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

    Time frame: Baseline to Month 6

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

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

    Time frame: Baseline to Month 9

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

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

    Time frame: Baseline to Month 12

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

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

    Time frame: Baseline to Month 18

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

  16. Proportion of treated eyes achieving complete success

    Time frame: Baseline to Month 4

    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.

  17. Proportion of treated eyes achieving complete success

    Time frame: Baseline to Month 6

    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.

  18. Proportion of treated eyes achieving complete success

    Time frame: Baseline to Month 9

    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.

  19. Proportion of treated eyes achieving complete success

    Time frame: Baseline to Month 12

    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.

  20. Proportion of treated eyes achieving complete success

    Time frame: Baseline to Month 18

    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.

  21. Proportion of treated eyes achieving qualified success

    Time frame: Baseline to Month 4

    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).

  22. Proportion of treated eyes achieving qualified success

    Time frame: Baseline to Month 6

    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).

  23. Proportion of treated eyes achieving qualified success

    Time frame: Baseline to Month 9

    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).

  24. Proportion of treated eyes achieving qualified success

    Time frame: Baseline to Month 12

    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).

  25. Proportion of treated eyes achieving qualified success

    Time frame: Baseline to Month 18

    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).

  26. Number of participants experiencing treatment emergent adverse events

    Time frame: Baseline to Month 18

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

ARGOS - A Phase IV, Prospective, 18-month Study to Assess the Effectiveness and Safety of Bimatoprost Intracameral Implant (DURYSTA) in US Clinical Practice

Acronym: ARGOS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 30, 2020
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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