Status:
TERMINATED
Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Ocular Therapeutix, Inc.
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 si...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04527887
Start Date
September 4 2020
End Date
December 31 2024
Last Update
January 15 2025
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111