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Eyelash Prostheses for Dry Eye Syndrome

N/A

Waitlist Available

Led By Michael Korenfeld, MD

Research Sponsored by D.E.L., LLC

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the secondary endpoint will be assessed 3 weeks after eyelash prosthesis placement in the interventional arm and the interventional arm and 5 weeks after initiation of eye drops in the active comparator arm

Awards & highlights

No Placebo-Only Group

Summary

This is a single-center, randomized, controlled trial to evaluate the safety and efficacy of eyelash prostheses versus 5.0% Lifitegrast BID, in 40 patients (20 randomized to each of two arms of the study) evaluated at 3 weeks and 5 weeks, respectively, after initiation of treatment.

Eligible Conditions

Dry Eye Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the primary endpoint will be assessed 3 weeks after eyelash prosthesis placement in the interventional arm and 5 weeks after initiation of eye drops in the active comparator arm

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the primary endpoint will be assessed 3 weeks after eyelash prosthesis placement in the interventional arm and 5 weeks after initiation of eye drops in the active comparator arm

This trial's timeline: 3 weeks for screening, Varies for treatment, and the primary endpoint will be assessed 3 weeks after eyelash prosthesis placement in the interventional arm and 5 weeks after initiation of eye drops in the active comparator arm for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Non-inferior change from baseline in tear break up time as measured by the Oculus Keratograph in the interventional subjects compared to the active control subjects

Secondary study objectives

Non-inferior change from baseline in SPEED II questionnaire in the treatment subjects compared to the control subjects

Non-inferior change in tear meniscus height as measured by the Oculus Keratograph in the treatment subjects compared to control subjects