Safety and Efficacy of Nanomicellar 0.09% Cyclosporine for Treatment of Dry Eye Disease Refractory to 0.05% Cyclosporine Emulsion: A Single-Arm Prospective Switch Study.

PURPOSE: The objective of this study was to evaluate the safety and efficacy of nanomicellar 0.09% cyclosporine in the treatment of dry eye disease (DED) recalcitrant to treatment with 0.05% cyclosporine emulsion. METHODS: We conducted a single-center single-arm prospective switch study. Adult patients with moderate-severe DED without improvement in symptoms after at least 6 months of treatment with emulsion cyclosporine 0.05% twice daily were included. Participants were switched, without washout, to twice-daily 0.09% cyclosporine in a nanomicellar vehicle and followed for 2 trial time points in addition to baseline: day 42 after switching and day 84 after switching. Our primary outcome was the corneal and interpalpebral staining score as defined by the Oxford scheme scale. Additional outcomes included tear break-up time (TBUT), Schirmer testing, tear osmolarity, Ocular Surface Disease Index (OSDI) score, global satisfaction score, and patient-reported adverse events. RESULTS: Over the course of the study, significant improvements were observed in corneal and interpalpebral staining (2.55 (0.18) at baseline to 1.79 (0.16) at study completion), TBUT (4.03 (0.31) at baseline to 6.76 (0.19) at study completion), OSDI score (43.64 (2.36) at baseline to 21.84 (1.71) at study completion), and global satisfaction score (55.59 (2.90) at baseline to 76.96 (1.52) at study completion). Nonsignificant improvements were also noted in Schirmer testing and tear osmolarity. No significant adverse events occurred. CONCLUSIONS: Nanomicellar 0.09% cyclosporine is safe and effective in managing DED in patients with symptoms refractory to 0.05% cyclosporine emulsion.