TABLE III.
Treatment-emergent adverse events reported in >2% of patients (safety population)
| CsA CE (n = 242) | Vehicle (n = 250) | |
|---|---|---|
| Any ocular TEAE, n (%) | 103 (42.6) | 67 (26.8) |
| Any treatment-related ocular TEAE,a n (%) | 92 (38.0) | 41 (16.4) |
| Eye irritation | 39 (16.1) | 6 (2.4) |
| Instillation site irritation | 22 (9.1) | 4 (1.6) |
| Eye pain | 17 (7.0) | 7 (2.8) |
| Lacrimation increased | 10 (4.1) | 1 (0.4) |
| Eyelid erythema | 9 (3.7) | 5 (2.0) |
| Meibomianitis | 6 (2.5) | 6 (2.4) |
| Conjunctival hyperemia | 6 (2.5) | 3 (1.2) |
| Any ocular SAE, n (%) | 1 (0.4) | 0 |
| Any severe ocular TEAE | 84 (34.7) | 40 (16.0) |
| Any severe treatment-related ocular TEAE, n (%) | 87 (36.0) | 28 (11.2) |
| Any ocular TEAE leading to study discontinuation, n (%) | 24 (9.9) | 18 (7.2) |
CsA CE = 0.1% cyclosporine A cationic emulsion; SAE = serious adverse event; TEAE = treatment-emergent adverse event.
a
Treatment-related TEAEs summarized here were deemed “definitely,” “probably,” or “possibly” related by the study investigator.