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Eyelash Prostheses vs. Lifitegrast BID for Dry Eye Disease

January 17, 2020

Overview

In this study, investigators are looking at the safety and efficacy of eyelash prostheses compared to 5.0% Lifitegrast BID Xiidra eye drops for dry eye disease. Participants will be split into the two groups and then be monitored and asked to report any adverse effects for 3-5 weeks.

 

Study Information

40 patients will be randomly split into the two groups: one will receive 5.0% Lifitegrast BID eye drops and the other will be given eyelash prostheses. They will then be evaluated – 3 weeks after the eyelash prostheses and 5 weeks after the eye drops. The eye drops will be given immediately at the first visit after giving consent and the eyelash prostheses require the subjects to come in for a second study visit about 2 weeks later for the application.

 

Inclusion Criteria

 

  • Self-reported dry eye symptoms
  • Tear Break Up Time of less than 10 seconds as assessed by the Oculus Keratograph (see Appendix A).
  • SPEED II Score greater than 25
  • Men or Women, age between 50 and 90 inclusive
  • Willingness to undergo both pre-treatment and post-treatment testing per the protocol
  • Willingness to endure the 2-3 hour time required to place eyelash extensions, if randomized to this treatment arm
  • Willingness to use eye drops for dry eyes and fill a prescription through insurance coverage, if randomized to this treatment arm
  • Willingness to attend all study visits
  • Willingness to sign informed consent and liability waiver

 

Exclusion Criteria

 

  • Absence of eyelashes
  • Eyelash disease such as clinically significant demodex, blepharitis, meibomitis
  • Be unable or unwilling to give written informed consent and/or to comply with study procedures.
  • Have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes.
  • Be unable to demonstrate correct installation of over the counter (OTC) ocular lubricant during Visit 1.
  • Have clinically significant ocular surface disease in either eye (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with study safety procedures, or assessments.
  • Have clinically significant systemic disease (e.g., uncontrolled diabetes, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study at Visit 1 and 2.
  • Current use of Restasis or Xiidra at the time of Visit 1
  • Changes in the dose of, or the initiation of, any medications that are known to affect dry eyes within 90 days of Visit 1 or during the duration of the study.
  • Any history of Herpes simplex of Herpes zoster affecting the eye or head.

 

Location

Comprehensive Eye Care

Washington, Missouri, United States, 63039

Contact: Michael Korenfeld, MD    636-390-3999 michaelkorenfeld@hotmail.com 

Principal Investigator: Michael Korenfeld, MD        

Sub-Investigator: Rita Hindmon

 

Sponsors/Collaborators

D.E.L., LLC

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