TerminatedPhase 4

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

Stopped: Per sponsor decision due to lengthy enrollment period

United States54 participantsStarted 2020-09-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in ocular inflammation

Timeframe: Change from Baseline one month after intracanalicular insert implantation or punctal plug

Trial details

NCT IDNCT04527887

SponsorTufts Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-17

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