In this meta-analysis, our aim was to systematically evaluate the efficacy and safety of lotilaner ophthalmic solution in treating Demodex Blepharitis (DB), with the goal of providing evidence for clinical practice. PubMed, Embase, Web of Science, The Cochrane Library, CNKI, Wanfang, and CBM were searched from inception to November 28, 2023. Randomized controlled trials (RCTs) comparing lotilaner ophthalmic solution (experimental group) with placebo (control group) for the treatment of DB were included. Two researchers independently screened the literature, extracted the data, and assessed the quality of the included studies. Meta-analysis was conducted using RevMan 5.4 software. The Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach was used to evaluate the evidence quality of outcomes. Publication bias was assessed using a funnel plot. Four RCTs involving 947 patients were included. Meta-analysis revealed that compared to placebo, lotilaner ophthalmic solution significantly increased the rate of mite eradication (RR = 3.61, 95% CI (2.90, 4.49), P < 0.00001). Additionally, lotilaner treatment resulted in higher rates of collarette cure, erythema cure, composite erythema/collarette cure, and clinically meaningful collarette cure; the differences were statistically significant, with effect sizes (RR = 5.74, 95% CI (4.27, 7.72), P < 0.00001), (RR = 3.16, 95% CI (2.18, 4.58), P < 0.00001), (RR = 6.75, 95% CI (3.75, 12.16), P < 0.00001), and (RR = 3.09, 95% CI (2.65, 3.60), P < 0.00001), respectively. Mite density (MD = –1.42, 95% CI (–2.09, –0.74), P < 0.0001) and collarette grade (MD = –1.51, 95% CI (–1.77, –1.25), P < 0.00001) were significantly reduced. Indeed, no discernible discrepancies in the comfort levels experienced with eye drops emerged between the two groups. Although the experimental group did exhibit a slightly higher occurrence of treatment-related adverse events, ranging from instillation site discomfort to eye discharge and eyelid swelling, these variances did not attain statistical significance. Notably, upon GRADE evaluation, the study’s evidence quality was deemed moderate, while scrutiny for publication bias revealed minimal indications thereof. In the realm of treatment, lotilaner ophthalmic solution shined as a beacon of efficacy, effectively combating mite infections and bolstering cure rates among patients with DB. Moreover, its administration was met with commendable compliance and upheld safety standards.
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