Eyelash Prostheses Compared to 5.0% Lifitegrast BID for Dry Eye Disease.

Status unconfirmed · Not applicable

Conditions studied: Dry Eye

In brief

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.

Key facts

Study ID

NCT03691636

Run by

D.E.L., LLC

People needed

40

Starts

2018-10-02

Expected to finish

2019-05-01

Last updated by the study team

2018-10-02

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Absence of eyelashes
• Eyelash disease such as clinically significiant 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 instillation 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.

Where it is running

• Comprehensive Eye Care — Washington, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.