18 Month Prospective Efficacy and Safety Study of Bimatoprost Intracameral Implant (DURYSTA)
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Bimatoprost intracameral implant (DURYSTA) 10μg | Patients with OAG or OHT who are scheduled for intracameral administration of a bimatoprost intracameral implant by their ophthalmologist. |
Recruiting Locations
Vanderbilt University Medical Center /ID# 244577
Nashville, Tennessee 37232-0011
Nashville, Tennessee 37232-0011
More Details
- Status
- Recruiting
- Sponsor
- Allergan