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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

Study 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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Eyelash ProsthesesExperimental Treatment1 Intervention
Each subject in this arm will receive eyelash prostheses according to a specified algorithm by a certified eyelash extensions.
Group II: 5.0% Lifitegrast Ophthalmic SolutionActive Control1 Intervention
Each subject in this arm will receive 5.0% Lifitegrast eye drops BID

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Who is running the clinical trial?

D.E.L., LLCLead Sponsor
Michael Korenfeld, MDPrincipal InvestigatorComprehensive Eye Care
1 Previous Clinical Trials
150 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Eyelash Prostheses Compared to 5.0% Lifitegrast BID for Dry Eye Disease.
2018. "Eyelash Prostheses Compared to 5.0% Lifitegrast BID for Dry Eye Disease.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03691636.
All > Xiidra > Dry Eye
~6 spots leftby Apr 2025
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