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

Elizabeth Yeu, David L Wirta, Paul Karpecki, Stephanie N Baba, Mark Holdbrook, Saturn I Study Group, Elizabeth Yeu, David L Wirta, Paul Karpecki, Stephanie N Baba, Mark Holdbrook, Saturn I Study Group

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.

Trial registration: ClinicalTrials.gov NCT04475432.

Conflict of interest statement

The authors have no funding or conflicts of interest to disclose.

Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

Figures

FIGURE 1.
FIGURE 1.
Grading scale (nonlinear) used for collarettes grading in each eyelid. *Grade 0–1: clinically meaningful; ǂfor an upper eyelid with 150 eyelashes, the number of eyelashes in upper eyelid may vary from 90 to 160.
FIGURE 2.
FIGURE 2.
Lid margin erythema grading scale (nonlinear).
FIGURE 3.
FIGURE 3.
Patient disposition flowchart.
FIGURE 4.
FIGURE 4.
Proportion of patients with clinically meaningful collarette cure (grade 0–1, ≤10 collarettes) in the upper eyelid of the analysis eye in the study and control groups.
FIGURE 5.
FIGURE 5.
Proportion of patients with complete collarette cure (grade 0, ≤2 collarettes) in the upper eyelid of the analysis eye in the study and control groups.
FIGURE 6.
FIGURE 6.
Proportion of patients with collarette improvement of at least 1 grade in the upper eyelid of the analysis eye in the study and control groups.
FIGURE 7.
FIGURE 7.
Proportion of patients with mite eradication (mite density of 0) in the study and control groups.
FIGURE 8.
FIGURE 8.
Proportion of patients achieving a mean mite density ≤0.5 mites/lash.
FIGURE 9.
FIGURE 9.
Proportion of patients with (A) erythema cure (grade 0) and (B) at least 1 grade erythema improvement at day 43 in the study and control groups.
FIGURE 10.
FIGURE 10.
Proportion of patients in the study and control groups who rated the drop as neutral to very comfortable.

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