Efficacy and Safety of Topical 0.05% Cyclosporine Eye Drops in the Treatment of Dry Eye Syndrome: A Systematic Review and Meta-analysis.

A systematic review was performed to evaluate the safety and efficacy of topical 0.05% cyclosporine in treating patients with dry eye syndrome (DES). Twelve qualified randomized-controlled trials incorporating 1367 patients were analyzed. In comparison to controls, patients who were on topical 0.05% cyclosporine eye drops had lower Ocular Surface Disease Index scores (mean difference [MD]=4.10, 95% CI: 0.25-7.96, P=.04), longer tear film breakup time (MD=2.30 seconds, 95% CI: 0.75-3.86, P=.004), improved Schirmer I scores (MD=2.77 mm/5min, 95% CI: 1.63-3.91, P=.00001), reduced corneal fluorescein staining (standardized mean difference [SMD]=0.61, 95% CI: 0.07-1.15, P=.03), and higher goblet cell densities (SMD=1.68, 95% CI: 0.54-2.81, P=.004). However, there were more adverse effects in the cyclosporine patient group (odds ratio=1.64, 95% CI: 1.17-2.30, P=.004). Topical 0.05% cyclosporine eye drops twice daily significantly improved both the objective and subjective outcomes in DES patients. The study limitations in the clinical, methodological and statistical heterogeneities are discussed.