Intracanalicular Dexamethasone Insert for Dry Eye Syndrome (DEcIDED Trial)

Phase 4

Recruiting

Led By Pedram Hamrah, MD

Research Sponsored by Tufts Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Dry Eye Disease

Be older than 18 years old

Must not have

Active ocular infection

History of Diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline one month after intracanalicular insert implantation or punctal plug

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing whether a dexamethasone insert can reduce symptoms of dry eye disease.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Dextenza may cause side effects like increased pressure inside the eye, discomfort at the insertion site, or possible risk of infection. Collagen plugs might lead to temporary irritation or excessive tearing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Dry Eye Disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an eye infection.

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I have a history of diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline one month after intracanalicular insert implantation or punctal plug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline one month after intracanalicular insert implantation or punctal plug

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline one month after intracanalicular insert implantation or punctal plug for reporting.