[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.