Topical cyclosporine effective in patients with mild dry eye disease

This prospective study revealed that topical cyclosporine (Restasis, Allergan, Inc., Irvine, Calif.) benefited patients will all categories of dry eye disease, especially patients with mild disease. Previous studies have examined the efficacy of cyclosporine for treating moderate to severe dry eye disease. This is the first study to investigate its effects in patient with mild disease. The authors suggested that early treatment of dry eye disease may yield the best results.

One hundred fifty-eight consecutive dry eye disease patients who were unresponsive to treatment with artificial tears were subjects in the study. They were classified as having mild, moderate or severe disease based on tear breakup time, fluorescein corneal staining, lissamine green conjunctival staining and Schirmer tear production test results. All patients were prescribed one drop of cyclosporine 0.05% twice daily for each eye and encouraged to continue using preservative-free artificial tears. They were followed for three to 16 months.

Treatment success was achieved in 104 of 143 patients (72.7 percent) treated for at least three months and in 104 of 158 patients (65.8 percent) who participated in the study, as measured by improvements in the Ocular Surface Disease Index. Among those who began the study, clinical improvement was seen in 46 of 62 patients (74.1 percent) with mild dry eye disease, 50 of 59 (72.4 percent) with moderate disease, and 18 of 27 (66.7 percent) with severe disease.

Fifteen patients failed to complete three months of treatment, of whom seven had mild dry eye disease, five moderate and three severe. They were all counted as treatment failures. Seven of them stopped treatment because of burning when applying cyclosporine during the first two weeks of treatment. All participants had been advised beforehand of this side effect during the initial two weeks of cyclosporine use. The authors hypothesized that the patients who stopped using cyclosporine due to adverse effects, lack of efficacy or indifference to treatment might have experienced positive effects if they had continued using the drops, since the largest number of patients who did not complete the therapy had mild disease and those with mild disease were the most satisfied with the treatment.

Financial Disclosures
Dr. Sheth has no financial interests to disclose.