Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis: Results of a Prospective, Randomized, Vehicle-Controlled, Double-Masked, Pivotal Trial (Saturn-1).

Abstract

PURPOSE:

The purpose of this study was to evaluate the safety and efficacy of lotilaner ophthalmic solution, 0.25%, compared with vehicle for the treatment of Demodex blepharitis.

METHODS:

In this prospective, randomized, controlled, double-masked, phase 2b/3 clinical trial, 421 patients with Demodex blepharitis were randomly assigned in a 1:1 ratio to receive either lotilaner ophthalmic solution, 0.25% (study group), or vehicle without lotilaner (control group) bilaterally, twice daily for 43 days. Patients were evaluated at days 8, 15, 22, and 43. Outcome measures were complete collarette cure (collarette grade 0), clinically meaningful collarette cure (grade 0 or 1), mite eradication (0 mites/lash), erythema cure (grade 0), composite cure (grade 0 for collarettes/erythema), and drop comfort. Adverse events were also evaluated.

RESULTS:

At day 43, the study group achieved a statistically significantly higher proportion of patients with clinically meaningful collarette cure (81.3% vs. 23.0%; P < 0.0001), complete collarette cure (44.0% vs. 7.4%; P < 0.0001), mite eradication (67.9% vs. 17.6%; P < 0.0001), erythema cure (19.1% vs. 6.9%; P = 0.0001), and composite cure (13.9% vs. 1.0%; P < 0.0001) than the control group. Nearly 92.0% of patients rated the study drop as neutral to very comfortable. All ocular adverse events in the study group were mild, with the most common being instillation site pain.

CONCLUSIONS:

Twice-daily treatment with a novel lotilaner ophthalmic solution, 0.25% for 43 days, is safe and effective for the treatment of Demodex blepharitis compared with the vehicle control.

• Authors: Elizabeth Yeu, David L Wirta, Paul Karpecki, Stephanie N Baba, Mark Holdbrook, Saturn I Study Group
• Journal: Cornea (Cornea) Vol. 42 Issue 4 Pg. 435-443 (Apr 01 2023) ISSN: 1536-4798 [Electronic] United States
• PMID: 35965392 (Publication Type: Randomized Controlled Trial, Journal Article)
• Copyright: Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

Chemical References

• Ophthalmic Solutions
• lotilaner

Topics

• Humans
• Ophthalmic Solutions
• Prospective Studies
• Double-Blind Method
• Blepharitis