Phase IIb/III findings
The trial had a multicenter, double-masked, parallel group design with three treatment arms: vehicle (n = 152) and two doses of the cyclosporine nanomicellar solution, 0.05% and 0.09% (n = 151 and n = 152, respectively).
After a 2-week vehicle run-in period, patients were treated for 12 weeks. Patients were not permitted to use artificial tears during the study, which was conducted at 29 sites in the United States.
Primary efficacy endpoints were conjunctival staining and the SANDE (Symptom Assessment iN Dry Eye) score. Secondary efficacy endpoints were corneal staining, tear film break-up time, and Schirmer’s test results. Of the patients enrolled, 426 completed the study, in the three groups, 144, 142, and 140, respectively.
Investigators reported that both drug concentrations were superior to the vehicle at all time points when analyzing the changes in conjunctival staining from baseline (0.05% concentration, p = 0.006; and 0.09% concentration, p = 0.008, compared with the vehicle).
Both concentrations also were superior to the vehicle in total and inferior corneal fluorescein staining at the final evaluation. Tear production was superior with both concentrations of the active treatment compared with the vehicle. The 0.09% drug concentration was significantly (p = 0.007) better compared with the vehicle and resulted in 17.9% of patients having a 10-mm or greater improvement on Schirmer’s testing compared with 7.6% of patients assigned to the vehicle.
Regarding the SANDE score, the three study arms showed an approximate 30% improvement in symptoms over the study course.