This prospective, single center, randomized, double-masked, parallel comparison, sponsored study seeks to investigate the efficacy of IDI on ameliorating the signs and symptoms of dry eye disease. The study aims to enroll 54 patients (36 Dextenza commercial formulation, 18 Collagen Plug) with DED.
DEcIDED
Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease
Dry eyes
All genders
18+
Recruiting now
Overview
Principal Investigator: Pedram Hamrah, MD
Contact Us
Nancy Gee
Study details
Inclusion Criteria
- Symptoms of DED such as foreign body sensation, burning, itching, stinging for at least 6 months
- Ocular Surface Disease Index (OSDI) score > 23
- Two or more of the following objective signs:
- Schirmer’s II test <10 mm at 5 minutes
- Tear break-up time (TBUT) of <10 seconds in one eye
- Corneal fluorescein staining of ≥4 (National Eye Institute grading scheme, 0-15) in at least one eye
- Conjunctival lissamine green staining of the nasal and temporal conjunctiva ≥4 (National Eye Institute grading scheme, 0-18) in at least
one eye
Exclusion Criteria
- History of diabetes
- History of ocular surgery, corneal infection, or corneal injury within the last 3 months
- Active ocular allergies, ocular infection or allergies to benzalkonium chloride “BAK” (an eye-drop preservative)
Study Requirements
3 visits: Screening, Baseline (which can be combined) and a follow up visit 1 month after.