Work

Systematic literature review and meta-analysis of lotilaner 0.25% and tea tree oil for Demodex blepharitis

Year: 2026

Type: review

Study designs: Systematic Review, Meta-Analysis

Abstract: Introduction: mite infestation. Currently, the only FDA-approved treatment for DB is lotilaner ophthalmic solution, 0.25%. Off-label therapies, including tea tree oil or terpinen-4-ol (collectively referred to as TTO) products, have also been used; however, supporting evidence is inconsistent. This systematic literature review and meta-analysis evaluated the treatment effects and quality of evidence for lotilaner ophthalmic solution, 0.25% and TTO products in patients with DB. Methods: MEDLINE, EMBASE, Cochrane CENTRAL, ClinicalTrials.gov, and ICTRP were searched from inception through July 10, 2025, to identify randomized controlled trials of lotilaner 0.25% or TTO. Results: Nine randomized controlled trials were included, with four evaluating lotilaner 0.25% versus vehicle and five evaluating TTO versus sham, comprising a total of 1,513 patients. Compared with vehicle, lotilaner 0.25% produced significantly lower mite density (mean difference -1.29 mites/lash at both 2-4 and 6-8 weeks; p<0.0001) and significantly higher odds of mite eradication (OR 4.70 at 2-4 weeks; OR 9.60 at 6-8 weeks), collarette reduction to 0-2 collarettes (OR 8.39 and 9.67), and erythema cure at 6-8 weeks (OR 3.91; all p<0.0001). TTO did not demonstrate a statistically significant difference versus sham for mite density or mite eradication at either timepoint. Discussion: These findings demonstrate a consistent, statistically significant benefit of lotilaner 0.25% across assessed outcomes compared with vehicle, supporting lotilaner 0.25% as an effective pharmacological treatment for DB. In contrast, randomized TTO studies were heterogeneous in product concentration, dosing regimen, and sham comparators and did not demonstrate a statistically significant effect on mite density or mite eradication versus sham comparators.

Source: Frontiers in Ophthalmology

DOI: 10.3389/fopht.2026.1978403