Demographic and baseline characteristics of patients included in the pooled full analysis set
| CsA CE (n=395) | Vehicle (n=339) | |
| SANSIKA study (n, %) | 154 (39.0) | 91 (26.8) |
| SICCANOVE study (n, %) | 241 (61.0) | 248 (73.2) |
| Mean age, years (SD) | 58.7 (13.2) | 59.5 (12.5) |
| Female, n (%) | 331 (83.8) | 291 (85.8) |
| Sjögren’s syndrome, n (%) | 147 (37.2) | 122 (36.0) |
| Severe DED, n (%) (CFS grade 4, OSDI ≥23) | 193 (48.9) | 126 (37.2) |
| HLA-DR data available, n (%) | 94 (23.8) | 74 (21.8) |
| CFS, mean (SD)—SANSIKA study | 4.00 (0.00) (n=154) | 4.00 (0.00) (n=90) |
| CFS, mean (SD)—SICCANOVE study | 2.83 (0.71) (n=241) | 2.80 (0.72) (n=248) |
| OSDI, mean (SD)—SANSIKA study | 61.4 (19.4) (n=154) | 58.8 (18.4) (n=91) |
| OSDI, mean (SD)—SICCANOVE study | 44.41 (21.94) (n=241) | 41.96 (21.84) (n=248) |
CFS, corneal fluorescein staining; CsA CE, 0.1% (1 mg/mL) ciclosporin A cationic emulsion; DED, dry eye disease; HLA-DR, human leucocyte antigen-DR; OSDI, Ocular Surface Disease Index.