Purpose. To evaluate the efficacy of marketed artificial tears in relieving the signs and symptoms of dry eye when used as supportive therapy to a cyclosporine-based ophthalmic emulsion.
Methods. Sixty-one patients were enrolled in this randomized, investigator-masked, parallel study of 6 months' duration. Eligible patients needed a Schirmer I score without anesthesia of 7 mm or less at day -7 and to answer that they needed artificial tears at least some of the time. Corneal staining of 3 or more (National Eye Institute grid, 15 points) at day -7 and day 0 in the same eye was also required. Patients were randomized to one of three regimens: Restasis (0.05% cyclosporine) twice per day with Systane used a minimum of once per day (Restasis + Systane); Restasis twice per day with Refresh Tears used a minimum of once per day (Restasis + Refresh); and Systane alone used four times per day. Signs and symptoms were measured at days -7, 0, 7, 14, 28, 42, 120, and 180.
Results. A statistical difference was seen in favor of Restasis + Systane versus Restasis + Refresh for corneal staining (P=0.0048) change from baseline and a trend (P=0.0725) for increased tear film breakup time at 6 months. There were no differences between treatment groups for Schirmer score, conjunctival staining, or conjunctival injection. Significant differences were seen in favor of Restasis + Systane versus Restasis + Refresh for less ocular burning (P=0.0210), stinging (P=0.0314), grittiness (P=0.0128), and dryness (P=0.0132). Systane was better than Restasis + Refresh for less burning (P=0.0288), dryness (P=0.0480), and scratchiness (P=0.0294).
Conclusions. Results indicate that the choice of concomitant therapy used with Restasis has significant effects on outcome measures. Both supportive therapies were compatible with Restasis.