Systematic Review and Meta-Analysis of Lotilaner Ophthalmic Solution 0.25% and Tea Tree Oil for Demodex Blepharitis

Document Type

Conference Proceeding

Publication Date

6-2026

Publication Title

Investigative Ophthalmology and Visual Science

Abstract

Purpose : Demodex blepharitis is a chronic inflammatory eyelid condition caused by Demodex mite infestation. Before the approval of lotilaner ophthalmic solution 0.25% by the FDA for the treatment of Demodex blepharitis, products containing tea tree oil or terpinen-4-ol (TTO) had been used widely for disease management. This systematic literature review and meta-analysis evaluated the current evidence of the effects of lotilaner 0.25% and TTO-containing products in patients with Demodex blepharitis.

Methods : MEDLINE, EMBASE, Cochrane CENTRAL, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP) were searched to identify English-language studies of adults with Demodex blepharitis published through July 2025. Data on collarette cure, mite eradication, and other symptom improvement were extracted. Meta-analysis of randomized controlled trials (RCTs) was performed to estimate pooled treatment effect sizes.

Results : Of 846 publications screened, 13 double-blind RCTs, 2 open-label RCTs, and 4 single-arm trials evaluated lotilaner 0.25% or TTO-based products. Six RCTs evaluating TTO and 4 evaluating lotilaner 0.25% were included in the meta-analyses. At 2 – 4 weeks, treatment with lotilaner 0.25% had greater odds of collarette cure (OR 8.39; 95% CI: 4.57-15.40; p< 0.0001) and mite eradication (OR 4.70; 95% CI: 3.35-6.59; p< 0.0001) vs vehicle. Treatment with TTO did not show statistically significant difference in mite eradication vs sham (OR 1.81; 95% CI: 0.62-5.26; p=0.274). Similarly, odds of collarette cure and mite eradication increased for lotilaner 0.25% vs vehicle at 6 – 8 weeks (OR 9.67 [95% CI: 6.64-14.08; p< 0.0001] and OR 9.60 [95% CI: 5.50-16.74; p< 0.0001], respectively). The observed effect in mite eradication for TTO vs sham showed no statistical difference (OR 1.47; 95% CI: 0.17-12.51; p=0.722).

Conclusions : Studies on lotilaner ophthalmic solution 0.25% had the highest quality of evidence with robust, prospective RCT designs. In contrast, studies assessing TTO products were limited by smaller sample sizes and less rigorous design. Lotilaner 0.25% demonstrated consistent and significant improvements in all efficacy outcomes evaluated whereas the treatment effect did not reach statistical significance for TTO for any outcomes evaluated.

Volume

67

Issue

7

First Page

5076

Comments

Association for Research in Vision and Ophthalmology (ARVO), May 3-7, 2026, Denver, CO

Last Page

5076

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