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An Evaluation of the Efficacy of a Cyclosporine-Based Dry Eye Therapy When Used With Marketed Artificial Tears as Supportive Therapy in Dry Eye

Sall, Ken N. M.D.; Cohen, Stephen M. O.D.; Christensen, Mike T. O.D., Ph.D.; Stein, Jerry M. Ph.D.

doi: 10.1097/01.icl.0000170599.57728.29

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.

From Sall Eye Care (K.N.S.), Bellflower, CA; Scottsdale, AZ (S.M.C.); and Alcon Research, Ltd. (M.T.C., J.M.S.), Fort Worth, TX.

Sponsored and supported by Alcon Research, Ltd., Fort Worth, TX.

Address correspondence and reprint requests to Dr. M.T. Christensen, Alcon Research, Ltd. (R6-15), 6201 South Freeway, Fort Worth, TX 76134; e-mail:

Accepted April 5, 2005.

© 2006 Lippincott Williams & Wilkins, Inc.