NCT03691636

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

A Single Center, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Eyelash Prostheses Compared to 5.0% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: D.E.L., LLC · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single center, randomized, controlled clinical trial to evaluate the tolerability, efficacy, and safety of eyelash prostheses over a 3-week period versus Xiidra BID over a 5 week period in subjects with self-reported DED. 40 subjects will be randomized to either eyelash prostheses or Xiidra, in a 1:1 ratio. At Visit 1 (screening), informed consent will be obtained from subjects and eligibility will then be determined. All pre-treatment assessments will be done at this visit. Randomization will occur. If randomized to receive Xiidra eye drops, a prescription will be written and the treatment will be started right away. If randomized to eyelash prostheses, then a second study visit will be made approximately 2 weeks later. Visit 2 (Eyelash Prostheses application) Subjects randomized to receive eyelash prostheses will have them applied approximately 2 weeks after the screening and randomization visit. Visit 3 (Final visit) will be 3 weeks post eyelash prosthesis placement and 5 weeks post Xiidra eye drop initiation. This was done to compare the maximal treatment effect between the two groups. All subjects will undergo post-treatment assessments. At each visit, patients will be asked to report any adverse events.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DEVICE	Eyelash prostheses	Eyelash prostheses are essentially specialized eyelash extensions
DEVICE	5.0% Lifitegrast Ophthalmic Solution	5.0% Lifitegrast Ophthalmic Solution

Timeline

• Start date: 2018-10-02
• Primary completion: 2019-04-02
• Completion: 2019-05-01
• First posted: 2018-10-02
• Last updated: 2018-10-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study