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