Ocular adverse events
ulcerative keratitis, Discontinuations, corneal leukoma, ocular TEAEs, Ocular TEAEs
ULCERATIVE KERATITIS, SEQUELAE
Ocular AEs followed the same pattern as overall AEs. Ocular TEAEs were reported for 29.2% of patients in the CsA CE high-dose group, 24.7% of the low-dose group, and 26.5% of those in the vehicle group. Most were mild or moderate in severity. There was 1 serious ocular AE of severe ulcerative keratitis in the CsA CE high-dose group that was considered unrelated to study treatment and that resolved with sequelae of corneal leukoma. Discontinuations due to ocular TEAEs were reported for 5.2% of patients in the CsA CE high-dose group, no patients in the low-dose group, and 8.2% of patients in the vehicle group.