[A prospective, observational, all-prescribed-patients study of cyclosporine 0.1% ophthalmic solution in the treatment of vernal keratoconjunctivitis].

PURPOSE: To evaluate the effectiveness and safety of topical cyclosporine 0.1% in patients with vernal keratoconjunctivitis (VKC). METHODS: All patients who were prescribed topical cyclosporine 0.1% during the 2 year period after market launch were registered and followed up for 6 months. We assessed the severity of 6 subjective ocular symptoms, such as itching and 10 objective signs, such as giant papillae in the tarsal conjunctiva. RESULTS: All scores for symptoms and signs in 2597 patients with VKC significantly decreased throughout a 6-month follow-up. For total symptoms scores, mean changes from baseline at 1, 3, and 6 months were -4.0, -4.8, and -5.1, respectively. Total sign scores were -4.6, -6.1, and -6.5, respectively. Thirty percent of topical steroid users were able to discontinue the steroids within 3 months. Adverse drug reactions (ADRs) were found in 7.44% of patients, the most common ADR being eye irritation. Ocular infections were observed in 1.44% of patients. During long-term use of topical cyclosporine 0.1%, there was no increase in the incidence of ADR and no late-onset ADRs. CONCLUSIONS: Topical cyclosporine 0.1% is an effective and safe treatment for VKC over the long term, provided care is exercised to avoid the occurrence of infection.