A randomized clinical evaluation of the safety of Systane® Lubricant Eye Drops for the relief of dry eye symptoms following LASIK refractive surgery

PURPOSE To evaluate the safety of Systane((R)) Lubricant Eye Drops in relieving the symptoms of dry eye following laser-assisted in situ keratomileusis (LASIK) surgery. METHODS This was a randomized, double-masked, single-center, placebo-controlled, contralateral eye study of 30 patients undergoing LASIK surgery. The mean age of patients was 42.4 +/- 10.7 years, and the mean spherical equivalent was -3.29 (range, +1.75 to -7.38). Patients' right and left eyes were randomized to receive either Systane((R)) or placebo - a preserved, thimerosal-free saline solution - beginning from the day of surgery and ending 30 days following surgery. Outcome measures included tear film break up time (TFBUT), visual acuity, degree of corneal and conjunctival staining, and treatment-related adverse events. RESULTS Preoperatively, placebo-treated eyes had statistically significantly higher sum corneal staining score than Systane((R))-treated eyes (p = 0.0464); however, the difference was clinically insignificant (p = 0.27). Two weeks post operatively, the average TFBUT in the Systane((R))-treated eyes was 1.23 seconds longer than that of the placebo-treated eyes (p = 0.028). All other evaluated variables were comparable between the two treatments. No adverse events were reported in the study. CONCLUSION Systane((R)) Lubricant Eye Drops are safe for use following LASIK surgery to relieve the discomfort symptoms of dry eye associated with the procedure.