PILOT TRIAL OF CYCLOSPORINE 1-PERCENT OPHTHALMIC OINTMENT IN THE TREATMENT OF KERATOCONJUNCTIVITIS SICCA

This trial was a randomized, double-masked, crossover study during whi ch patients with keratoconjunctivitis sicca underwent 6 weeks of treat ment with either cyclosporine 1% ophthalmic ointment or placebo follow ed by 6 weeks of the alternative treatment. Washout periods using only unpreserved artificial tears preceded both treatment cycles. Twenty-f ive patients completed the first treatment period, but only eight met entry criteria for period II. Cyclosporine ointment was associated wit h initial mild to moderate redness, itching, and burning that returned to baseline levels within 1-2 weeks. Rose Bengal results and results of four subjective (patient diary) efficacy parameters favored cyclosp orine: foreign body sensation, overall symptoms, hours of symptom cont rol per day, and overall effectiveness. No systemic adverse events or laboratory abnormalities occurred. We conclude that (a) the crossover design is inappropriate for studying this disease; (b) mild to moderat e itching, redness, and burning occur initially with cyclosporine admi nistration, although tolerance quickly develops; (c) cyclosporine appe ars to benefit the ocular surface in keratoconjunctivitis sicca; and ( d) further trials in this syndrome are warranted.