Treatment of Demodex Blepharitis: A Prospective, Randomized, Controlled, Double-Masked Clinical Trial Comparing Topical Lotilaner Ophthalmic Solution, 0.25% Eyedrops to Vehicle

ABSTRACT

Purpose

To evaluate the efficacy and safety of lotilaner ophthalmic solution, 0.25% eyedrops compared to vehicle for the treatment of Demodex blepharitis.

Methods

In this randomized, controlled, double-masked clinical trial, 54 participants were randomly assigned in a 1:1 ratio to receive either lotilaner ophthalmic solution, 0.25% (study group) or the vehicle (control group) bilaterally, twice daily for 42 days. Outcome measures were collarette cure (collarette grade 0, upper eyelid), mite eradication (mite density of 0 mites/lash), and composite cure (grade 0 for collarettes and erythema).

Results

The proportion of participants achieving collarette cure (80.0% vs 15.8%; p < .001), mite eradication (73.3% vs 21.1%, p = .003) and composite cure (73.3% vs 10.5%, p < .001) at Day 42 was statistically significantly higher in the study group than the control group.

Conclusion

Twice-daily 42-day treatment with novel lotilaner ophthalmic solution, 0.25% is safe and effective for the treatment of Demodex blepharitis compared to the vehicle control. (Registry number: ACTRN12620000320954, dated 09/03/2020).

KEYWORDS:

• Blepharitis
• collarettes
• cylindrical dandruff
• Demodex
• lotilaner
• mites
• ocular surface disease
• TP-03

Acknowledgments

Jan Beiting (Wordsmith Consulting, Cary, North Carolina) and Raman Bedi, MD (IrisARC -Analytics, Research & Consulting, Chandigarh, India) provided editorial assistance in the preparation of this manuscript.

Disclosure statement

EY and HQM have received consulting fees from Tarsus Pharmaceuticals. MH and SNB are employees of Tarsus Pharmaceuticals. For the remaining authors, no conflicts are declared.

Additional information

Funding

This study was funded via a grant from Tarsus Pharmaceuticals to Asociacion para Evitar la Ceguera en Mexico I.A.P.