Topical cyclosporine A for the treatment of dry eye: a randomized clinical study

Aim The aim of this study was to determine the efficacy and safety of topical cyclosporine A (CsA) in treatment of moderate-to-severe dry eye. Setting and design This is a prospective randomized comparative clinical study that was carried out at Alexandria Main University Hospital, Alexandria, Egypt. Patients and methods The study included 80 eyes of 40 patients with moderate-to-severe dry eye. Patients were divided into two groups: group I received topical CsA 0.05%, and group II were controls. Patients were assessed at weeks 1, 4, and 12 during and after the treatment phase for changes from the baseline using Schirmer's test, tear break-up time (TBUT), fluorescein staining, and Ocular Surface Disease Index (OSDI). Results There were greater improvements in group I than in group II in Schirmer's test results (P=0.002), TBUT (P=0.001), and OSDI scores (P=0.009) at week 4. At week 12 posttreatment phase, the improvement in group I kept on more slowly toward stability for Schirmer's test (P=0.004) and TBUT (P=0.002), whereas the improvement in fluorescein staining and OSDI scores was not significant (P=0.706 and 0.065, respectively). Conclusion CsA ophthalmic oily solution 0.05% was demonstrated to be effective. It decreased the manifestations of dry-eye disease. Additionally, its effect continued to occur significantly within the treatment periods and the improvement of the ocular condition kept on, actually, more slowly toward stability, although the drug was already discontinued.