Efficacy and safety of preservative-free 0.02% tacrolimus eye drops in vernal keratoconjunctivitis: a retrospective case series

Topical tacrolimus has been widely used in recent years to treat allergic conjunctivitis. Various formulations and concentrations exist, although tolerance can sometimes be limited. This retrospective study evaluated the efficacy and safety of preservative-free 0.02% tacrolimus eye drops in patients with vernal keratoconjunctivitis (VKC). This single-center, retrospective, observational case series included 21 patients diagnosed with VKC, treated with preservative-free 0.02% tacrolimus for at least six months between January 2022 and December 2024. Demographic and clinical data were collected from the patients’ medical records. Clinical outcomes were assessed using subjective ocular symptoms, objective ocular signs, and a clinical functional score calculated at baseline and at 6 months. Among 21 patients, 20 (95.2%) were male, mean age was 7.5 ± 2.5 years (range, 3–12.8 years). Ten (47.6%) had mixed VKC, 9 (42.9%) had palpebral form, and 2 (9.5%) had limbal form. Four (19.0%) had atopic conditions, and 16 (76.2%) had treated allergies, whilst 20 (95.0%) patients had previously used topical ciclosporin (0.1–2%). All patients received topical preservative-free 0.02% tacrolimus twice daily for 7.1 ± 4.1 months (range, 6–24 months). The mean functional score before tacrolimus 0.02% treatment was 2.6 ± 2.3 (range 0–8), which decreased to 0.4 ± 0.9 (range, 0–4) at Month 6. A patient-level linear mixed-effects model showed a significant reduction in the score between T0 and T2 (estimated difference: −2.67 points; 95% CI: −3.76 to − 1.57; p < 0.001). No adverse events were recorded, and the treatment was well tolerated. Preservative-free 0.02% tacrolimus eye drops were associated with clinical improvement and were well tolerated in patients with VKC.