The efficacy and safety of nanoemulsion compared to conventional cyclosporine in dry eye disease: A systematic review and meta-analysis

Abstract

To evaluate the efficacy and safety of nanoemulsion cyclosporine compared to conventional cyclosporine in reducing symptoms of dry eye disease (DED). A systematic review and meta-analysis. We searched Scopus, Web of Science, PubMed, Embase, and Cochrane for relevant randomized clinical trials (RCTs) and pooled the mean differences (MD) for continuous efficacy outcomes, including the Schirmer test, ocular surface disease index (OSDI), and tear film break-up time (TBUT), and risk ratios (RR) for dichotomous safety outcomes, such as adverse drug reactions or ocular adverse events, with their corresponding 95% confidence intervals (CI) across different time points from baseline. We used R statistical software to run the meta-analysis and I² statistic to assess heterogeneity. Seven RCTs involving 545 patients were included. At 12 weeks, nanoemulsion cyclosporine significantly improved tear production as measured by the Schirmer test (MD = 0.77 mm, 95% CI, 0.22 to 1.31, p < 0.01) and tear film stability assessed by TBUT (MD = 0.51 seconds, 95% CI, 0.32 to 0.70, p < 0.01) compared to conventional cyclosporine. Safety analysis showed no significant difference in overall adverse events between groups (RR = 1.13, 95% CI, 0.81 to 1.56, p = 0.44). However, nanoemulsion cyclosporine was associated with a significantly higher risk of ocular adverse events (RR = 3.53, 95% CI, 1.18 to 10.54, p = 0.02). Our meta-analysis demonstrates that nanoemulsion cyclosporine significantly improves tear production and tear film stability at the longest available follow-up. However, it is also associated with an increased risk of ocular adverse events. These findings highlight the need to balance efficacy and safety when considering nanoemulsion cyclosporine and could help inform clinical guidelines on optimal treatment duration and monitoring.