Clinical evaluation of the additive effect of diquafosol tetrasodium on sodium hyaluronate monotherapy in patients with dry eye syndrome: a prospective, randomized, multicenter study

Purpose To assess the additive effect of diquafosol tetrasodium on sodium hyaluronate monotherapy in patients with dry eye syndrome. Methods This study evaluated 64 eyes of 32 patients (age: 62.6 +/- 12.8 years (mean +/- SD)) in whom treatment with 0.1% sodium hyaluronate was insufficiently responsive. The eyes were randomly assigned to one of the two regimens in each patient: topical administration of sodium hyaluronate and diquafosol tetrasodium in one eye, and that of sodium hyaluronate in the other. Before treatment, and 2 and 4 weeks after treatment, we determined tear volume, tear film breakup time (BUT), fluorescein and rose bengal vital staining scores, subjective symptoms, and adverse events. Results We found a significant improvement in BUT (P = 0.049, Dunnett test), fluorescein and rose bengal staining scores (P = 0.02), and in subjective symptoms (P = 0.004 for dry eye sensation, P = 0.02 for pain, and P = 0.02 for foreign body sensation) 4 weeks after treatment in the diquafosol eyes. On the other hand, we found no significant change in these parameters after treatment in the control eyes. Conclusions In dry eyes, where sodium hyaluronate monotherapy was insufficient, diquafosol tetrasodium was effective in improving objective and subjective symptoms, suggesting its viability as an option for the additive treatment of such eyes. Eye (2012) 26, 1363-1368; doi:10.1038/eye.2012.166; published online 10 August 2012