Intracanalicular Dexamethasone Insert for Dry Eye Syndrome
(DEcIDED Trial)

Recruiting in Palo Alto (17 mi)

Overseen byPedram Hamrah, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Tufts Medical Center

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Pedram Hamrah, MD

Principal Investigator

Tufts Medical Center

Eligibility Criteria

This trial is for individuals with Dry Eye Disease confirmed by specific tests and visible eye inflammation. It's not suitable for those who've had recent eye surgery, infections, injuries, diabetes, active ocular allergies or an allergy to benzalkonium chloride.

Inclusion Criteria

I have been diagnosed with 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

You are allergic to benzalkonium chloride.

I have not had eye surgery, corneal infection, or injury in the last 3 months.

I currently have an eye infection.

See 2 more

Treatment Details

Interventions

Dextenza (IDI) (Sustained Release Dexamethasone) (Corticosteroid)
ProLong™ collagen plugs (Other)

Trial OverviewThe study is testing the effectiveness of a Dexamethasone insert called Dextenza against ProLong™ collagen plugs in reducing symptoms of dry eye disease. Participants are randomly assigned to one of these treatments in a controlled environment.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg)Active Control1 Intervention

intracanalicular dexamethasone insert

Group II: ProLong™ collagen plugsPlacebo Group1 Intervention

collagen plug