Overview

Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)

Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
Summary
This prospective, single-center, randomized, double-masked, parallel comparison, sponsored study seeks to investigate the efficacy of Intracanalicular dexamethasone Insert (IDI) on ameliorating the signs and symptoms of dry eye disease.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tufts Medical Center
Collaborator:
Ocular Therapeutix, Inc.
Treatments:
Dexamethasone
Criteria
Inclusion Criteria:

- Diagnosis of Dry Eye Disease

- Objective Signs (Schirmer's II test <10 mm at 5 min; Tear Break-Up time (TBUT) of <10
seconds in 1 eye; corneal fluorescein staining of .=4 in at least 1 eye; conjunctival
lissamine green staining of the nasal and temporal conjunctive >=4 in at least 1 eye)

- Ocular inflammation presence confirmed by In-Vivo Confocal Microscopy

Exclusion Criteria:

- History of Diabetes

- History of ocular surgery, corneal infection, or corneal injury within the last 3
months

- Active ocular allergies

- Active ocular infection

- Allergic to benzalkonium chloride