Evaluation of topical cyclosporine for the treatment of dry eye disease.

Objective: To evaluate the use of topical cyclosporine, 0.05% (Restasis; Allergan Inc, Irvine, California), for the treatment of mild, moderate, and severe dry eye disease unresponsive to artificial tears therapy.

Methods: This was a prospective clinical study. One hundred fifty-eight consecutive patients with dry eye disease unresponsive to artificial tears therapy were divided into 3 groups of disease severity: mild, moderate, and severe. Patients were evaluated using the Ocular Surface Disease Index for symptomatic improvement, tear breakup time, fluorescein staining, lissamine green staining, and Schirmer testing. Patients were observed for 3 to 16 months. The main outcome measure was improvement in disease.

Results: Forty-six of 62 patients with mild dry eye disease (74.1%), 50 of 69 with moderate disease (72.4%), and 18 of 27 with severe disease (66.7%) showed improvement, with 72.1% improving overall.

Conclusions: Topical cyclosporine shows beneficial effects in all categories of dry eye disease. Symptomatic improvement was greatest in the mild group and the best results in improvement of disease signs were in patients with severe dry eye disease.