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

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).