Open-angle GlaucomaARGOSNCT04647214
18 Month Prospective Efficacy and Safety Study of Bimatoprost Intracameral Implant (DURYSTA)
An observational study of Open-angle Glaucoma and Ocular Hypertension, run by Allergan at 39 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma, Ocular Hypertension
- How many people
- 220 participants
- Where
- 39 sitesUnited States
- Study dates
- 3 Mar 2021to 12 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patient diagnosed with OAG or OHT who is scheduled to receive a bimatoprost intracameral implant in at least one eye.
Who cannot join
- 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.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Georgia Eye Partners /ID# 240061
Atlanta, Georgia, 30342
John Hopkins Wilmer Eye Institute /ID# 243701
Bethesda, Maryland, 20817-1805
Midwest Vision Research Foundation at Pepose Vision Institute /ID# 240537
Chesterfield, Missouri, 63017
Colorado Eye Institute /ID# 240798
Colorado Springs, Colorado, 80924-7003
Scott and Christie and Associates /ID# 244574
Cranberry Township, Pennsylvania, 16066
Angeles Eye Institute /ID# 240368
Culver City, California, 90232
Glaucoma Associates of Texas /ID# 240682
Dallas, Texas, 75231
Glaucoma Associates of Texas /ID# 253289
Dallas, Texas, 75231
META Medical Research Institute, LLC /ID# 240800
Dayton, Ohio, 45432-1400
Eye Associates of North Jersey /ID# 244585
Dover, New Jersey, 07801-1629
Duke Eye Center /ID# 244478
Durham, North Carolina, 27705
El Paso Eye Surgeons, P.A. /ID# 240366
El Paso, Texas, 79902
Kovach Eye Institute /ID# 244581
Elmhurst, Illinois, 60126-2821
Bergstrom Eye Research LLC /ID# 240363
Fargo, North Dakota, 58103
Eye Associates of Fort Meyers /ID# 244476
Fort Myers, Florida, 33901
ICON Eye Care /ID# 240681
Grand Junction, Colorado, 81501-8180
Hudson Eye /ID# 240805
Jersey City, New Jersey, 07306-2929
Wiles Eye Center /ID# 240808
Kansas City, Missouri, 64118-4390
Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240364
La Jolla, California, 92093
Glaucoma Care Center /ID# 252021
Livingston, New Jersey, 07039
American Institute of Research /ID# 247820
Los Angeles, California, 90027
The Eye Care Institute /ID# 240367
Louisville, Kentucky, 40206
MedEye Associates /ID# 240374
Miami, Florida, 33143
DCT Shah Eye Research Institut /ID# 240375
Mission, Texas, 78572
Vanderbilt University Medical Center /ID# 244577
Nashville, Tennessee, 37232-0011
MaculaCare PLLC /ID# 244593
New York, New York, 10021
Oklahoma Eye Surgeons /ID# 240373
Oklahoma City, Oklahoma, 73112
New York New Jersey Eye Institute /ID# 244590
Orangeburg, New York, 10962-2185
Stiles Eyecare Excellence /ID# 240376
Overland Park, Kansas, 66213
North Bay Eye Associates Inc. /ID# 240362
Petaluma, California, 94954-2387
The Eye Centers of Racine and Kenosha LTD /ID# 240059
Racine, Wisconsin, 53405
Pacific Eye Associates /ID# 240536
San Francisco, California, 94115
Center for Sight - Sarasota /ID# 244578
Sarasota, Florida, 34239
Newsom Eye & Laser Center /ID# 253287
Sebring, Florida, 33870
Ophthalmology Associates /ID# 240799
St Louis, Missouri, 63131
Dr. Andrew Gardner Logan, FL /ID# 240361
Tamarac, Florida, 33321
New York Eye Surgery Associates, PLLC /ID# 244592
The Bronx, New York, 10469
Your Eye Specialists /ID# 253286
Weston, Florida, 33326
Burlington County Eye Physicians /ID# 244594
Willingboro, New Jersey, 08046-1109
About this study
Official title: ARGOS - A Phase IV, Prospective, 18-month Study to Assess the Effectiveness and Safety of Bimatoprost Intracameral Implant (DURYSTA) in US Clinical Practice
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).
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost intracameral implant (DURYSTA) 10μg | Patients with OAG or OHT who are scheduled for intracameral administration of a bimatoprost intracameral implant by their ophthalmologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Month 6
Secondary outcomes (26)
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.
Measured: Baseline to Month 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.
Measured: Baseline to Month 9
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.
Measured: Baseline to Month 12
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.
Measured: Baseline to Month 18
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.
Measured: Baseline to Month 18
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.
Measured: Baseline to Month 4
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.
Measured: Baseline to Month 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.
Measured: Baseline to Month 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.
Measured: Baseline to Month 12
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.
Measured: Baseline to Month 18
Mean reduction in the number of topical IOP-lowering medications
A numerical count by class of drug of topical IOP lowering medications being taken.
Measured: Baseline to Month 4
Mean reduction in the number of topical IOP-lowering medications
A numerical count by class of drug of topical IOP lowering medications being taken.
Measured: Baseline to Month 6
Mean reduction in the number of topical IOP-lowering medications
A numerical count by class of drug of topical IOP lowering medications being taken.
Measured: Baseline to Month 9
Mean reduction in the number of topical IOP-lowering medications
A numerical count by class of drug of topical IOP lowering medications being taken.
Measured: Baseline to Month 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.
Measured: Baseline to Month 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.
Measured: Baseline to Month 4
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.
Measured: Baseline to Month 6
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.
Measured: Baseline to Month 9
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.
Measured: Baseline to Month 12
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.
Measured: Baseline to Month 18
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).
Measured: Baseline to Month 4
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).
Measured: Baseline to Month 6
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).
Measured: Baseline to Month 9
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).
Measured: Baseline to Month 12
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).
Measured: Baseline to Month 18
Number of participants experiencing treatment emergent adverse events
Measured: Baseline to Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start3 Mar 2021
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open-angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ALLERGAN INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647214
- Sponsor's protocol ID
- MED-MA-EYE-0648
- Acronym
- ARGOS
- Status last verified
- Jul 2025
- First submitted
- 23 Nov 2020
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARGOS - A Phase IV, Prospective, 18-month Study to Assess the Effectiveness and Safety of Bimatoprost Intracameral Implant (DURYSTA) in US Clinical Practice
- ClinicalTrials.gov ID
- NCT04647214
- Acronym / sponsor ID
- ARGOS / MED-MA-EYE-0648
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost intracameral implant (DURYSTA) 10μg | – | –Patients with OAG or OHT who are scheduled for intracameral administration of a bimatoprost intracameral implant by their ophthalmologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patient diagnosed with OAG or OHT who is scheduled to receive a bimatoprost intracameral implant in at least one eye.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
26 secondary outcomes
Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care
Time frame: Baseline to Month 4
Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care
Time frame: Baseline to Month 9
Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care
Time frame: Baseline to Month 12
Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care
Time frame: Baseline to Month 18
Time from bimatoprost intracameral implant to first additional IOP-lowering intervention/therapy
Time frame: Baseline to Month 18
Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy
Time frame: Baseline to Month 4
Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy
Time frame: Baseline to Month 6
Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy
Time frame: Baseline to Month 9
Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy
Time frame: Baseline to Month 12
Proportion of treated eyes achieving predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy
Time frame: Baseline to Month 18
Mean reduction in the number of topical IOP-lowering medications
Time frame: Baseline to Month 4
Mean reduction in the number of topical IOP-lowering medications
Time frame: Baseline to Month 6
Mean reduction in the number of topical IOP-lowering medications
Time frame: Baseline to Month 9
Mean reduction in the number of topical IOP-lowering medications
Time frame: Baseline to Month 12
Mean reduction in the number of topical IOP-lowering medications
Time frame: Baseline to Month 18
Proportion of treated eyes achieving complete success
Time frame: Baseline to Month 4
Proportion of treated eyes achieving complete success
Time frame: Baseline to Month 6
Proportion of treated eyes achieving complete success
Time frame: Baseline to Month 9
Proportion of treated eyes achieving complete success
Time frame: Baseline to Month 12
Proportion of treated eyes achieving complete success
Time frame: Baseline to Month 18
Proportion of treated eyes achieving qualified success
Time frame: Baseline to Month 4
Proportion of treated eyes achieving qualified success
Time frame: Baseline to Month 6
Proportion of treated eyes achieving qualified success
Time frame: Baseline to Month 9
Proportion of treated eyes achieving qualified success
Time frame: Baseline to Month 12
Proportion of treated eyes achieving qualified success
Time frame: Baseline to Month 18
Number of participants experiencing treatment emergent adverse events
Time frame: Baseline to Month 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Derived from this study: PubMed 39946034Mann 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.
- Individual participant dataSharing planned: Undecided
Related trials for Open-angle Glaucoma
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALLERGAN INC. study director
Allergan
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open-angle Glaucoma and Ocular Hypertension, run by Allergan at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04647214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.