Clinical trial NCT04647214: 18 Month Prospective Efficacy and Safety Study of Bimatoprost Intracameral Implant (DURYSTA)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open-angle Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2020-11-30
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of treated eyes that did not receive additional Intraocular Pressure (IOP) -lowering intervention/therapy per standard medical care
timeFrame: Baseline to Month 6
Secondary outcomes:
measure: Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care
timeFrame: Baseline to Month 4
measure: Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care
timeFrame: Baseline to Month 9
measure: Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care
timeFrame: Baseline to Month 12
measure: Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care
timeFrame: Baseline to Month 18
measure: Time from bimatoprost intracameral implant to first additional IOP-lowering intervention/therapy
timeFrame: Baseline to Month 18
measure: Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy
timeFrame: Baseline to Month 4
measure: Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy
timeFrame: Baseline to Month 6
measure: Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy
timeFrame: Baseline to Month 9
measure: Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy
timeFrame: Baseline to Month 12
measure: Proportion of treated eyes achieving predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy
timeFrame: Baseline to Month 18
measure: Mean reduction in the number of topical IOP-lowering medications
timeFrame: Baseline to Month 4
measure: Mean reduction in the number of topical IOP-lowering medications
timeFrame: Baseline to Month 6
measure: Mean reduction in the number of topical IOP-lowering medications
timeFrame: Baseline to Month 9
measure: Mean reduction in the number of topical IOP-lowering medications
timeFrame: Baseline to Month 12
measure: Mean reduction in the number of topical IOP-lowering medications
timeFrame: Baseline to Month 18
measure: Proportion of treated eyes achieving complete success
timeFrame: Baseline to Month 4
measure: Proportion of treated eyes achieving complete success
timeFrame: Baseline to Month 6
measure: Proportion of treated eyes achieving complete success
timeFrame: Baseline to Month 9
measure: Proportion of treated eyes achieving complete success
timeFrame: Baseline to Month 12
measure: Proportion of treated eyes achieving complete success
timeFrame: Baseline to Month 18
measure: Proportion of treated eyes achieving qualified success
timeFrame: Baseline to Month 4
measure: Proportion of treated eyes achieving qualified success
timeFrame: Baseline to Month 6
measure: Proportion of treated eyes achieving qualified success
timeFrame: Baseline to Month 9
measure: Proportion of treated eyes achieving qualified success
timeFrame: Baseline to Month 12
measure: Proportion of treated eyes achieving qualified success
timeFrame: Baseline to Month 18
measure: Number of participants experiencing treatment emergent adverse events
timeFrame: Baseline to Month 18
Other outcomes:
Locations:
city: Culver City
country: United States
facility: Angeles Eye Institute /ID# 240368
state: California
city: La Jolla
country: United States
facility: Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240364
state: California
city: Los Angeles
country: United States
facility: American Institute of Research /ID# 247820
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates Inc. /ID# 240362
state: California
city: San Francisco
country: United States
facility: Pacific Eye Associates /ID# 240536
state: California
city: Colorado Springs
country: United States
facility: Colorado Eye Institute /ID# 240798
state: Colorado
city: Grand Junction
country: United States
facility: ICON Eye Care /ID# 240681
state: Colorado
city: Fort Myers
country: United States
facility: Eye Associates of Fort Meyers /ID# 244476
state: Florida
city: Miami
country: United States
facility: MedEye Associates /ID# 240374
state: Florida
city: Sarasota
country: United States
facility: Center for Sight - Sarasota /ID# 244578
state: Florida
city: Sebring
country: United States
facility: Newsom Eye & Laser Center /ID# 253287
state: Florida
city: Tamarac
country: United States
facility: Dr. Andrew Gardner Logan, FL /ID# 240361
state: Florida
city: Weston
country: United States
facility: Your Eye Specialists /ID# 253286
state: Florida
city: Atlanta
country: United States
facility: Georgia Eye Partners /ID# 240061
state: Georgia
city: Elmhurst
country: United States
facility: Kovach Eye Institute /ID# 244581
state: Illinois
city: Overland Park
country: United States
facility: Stiles Eyecare Excellence /ID# 240376
state: Kansas
city: Louisville
country: United States
facility: The Eye Care Institute /ID# 240367
state: Kentucky
city: Bethesda
country: United States
facility: John Hopkins Wilmer Eye Institute /ID# 243701
state: Maryland
city: Chesterfield
country: United States
facility: Midwest Vision Research Foundation at Pepose Vision Institute /ID# 240537
state: Missouri
city: Kansas City
country: United States
facility: Wiles Eye Center /ID# 240808
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Associates /ID# 240799
state: Missouri
city: Dover
country: United States
facility: Eye Associates of North Jersey /ID# 244585
state: New Jersey
city: Jersey City
country: United States
facility: Hudson Eye /ID# 240805
state: New Jersey
city: Livingston
country: United States
facility: Glaucoma Care Center /ID# 252021
state: New Jersey
city: Willingboro
country: United States
facility: Burlington County Eye Physicians /ID# 244594
state: New Jersey
city: Bronx
country: United States
facility: New York Eye Surgery Associates, PLLC /ID# 244592
state: New York
city: New York
country: United States
facility: MaculaCare PLLC /ID# 244593
state: New York
city: Orangeburg
country: United States
facility: New York New Jersey Eye Institute /ID# 244590
state: New York
city: Durham
country: United States
facility: Duke Eye Center /ID# 244478
state: North Carolina
city: Fargo
country: United States
facility: Bergstrom Eye Research LLC /ID# 240363
state: North Dakota
city: Dayton
country: United States
facility: META Medical Research Institute, LLC /ID# 240800
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Eye Surgeons /ID# 240373
state: Oklahoma
city: Cranberry Township
country: United States
facility: Scott and Christie and Associates /ID# 244574
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center /ID# 244577
state: Tennessee
city: Dallas
country: United States
facility: Glaucoma Associates of Texas /ID# 240682
state: Texas
city: Dallas
country: United States
facility: Glaucoma Associates of Texas /ID# 253289
state: Texas
city: El Paso
country: United States
facility: El Paso Eye Surgeons, P.A. /ID# 240366
state: Texas
city: Mission
country: United States
facility: DCT Shah Eye Research Institut /ID# 240375
state: Texas
city: Racine
country: United States
facility: The Eye Centers of Racine and Kenosha LTD /ID# 240059
state: Wisconsin
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: