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

Allergan

Status: Completed

Conditions: Open-angle Glaucoma; Ocular Hypertension

Study type: Observational

Funder types: Industry

Identifiers

NCT04647214

MED-MA-EYE-0648

Details and patient eligibility

About

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).

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

220 participants in 1 patient group

Bimatoprost intracameral implant (DURYSTA) 10μg

Description:

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