Table 4.
Safety analysis: treatment-related adverse events (29 AEs/68 subjects)
| Treatment group | ||
|---|---|---|
| PRO-122 | KOF | |
| Patients with AEs, n (%) | 18 (26.5) | 11 (16.2) |
| Non-ocular AEs, n (%) | 15 (83.3) | 7 (63.6) |
| Rhinopharyngitis, n (%) | 6 (33.3) | 2 (18.2) |
| Headache, n (%) | 2 (11.1) | 0 (0) |
| Acid peptic disease, n (%) | 0 (0) | 2 (18.2) |
| Other, n (%) | 7 (38.9) | 3 (27.3) |
| Ocular AEs, n (%) | 3 (16.7) | 4 (36.4) |
| Conjunctivitis, n (%) | 2 (11.1) | 1 (9.1) |
| Other, n (%) | 1 (5.6) | 3 (27.3) |
No significant differences between groups, all p values (X2 Pearson) were > 0.05