Table 3.
Treatment-Emergent Adverse Events Possibly or Definitely Related to Study Treatment (Safety Population)
| Reproxalapa (n = 15) | Reproxalapa + Prednisoloneb(n = 16) | Prednisoloneb (n = 14) | |
|---|---|---|---|
| Any AE | 4 (27) | 4 (25) | 0 |
| Preferred term | |||
| Eye irritation | 3 (20) | 2 (13) | 0 |
| Eye pain | 1 (7) | 1 (6) | 0 |
| Headache | 1 (7) | 1 (6) | 0 |
| Eye pruritus | 1 (7) | 0 | 0 |
| Macular edema | 0 | 1 (6) | 0 |
| Ocular hyperemia | 0 | 1 (6) | 0 |
Data are presented as n (%).
a
Reproxalap ophthalmic drops 0.5%.
b
Prednisolone 1% ophthalmic solution.
AE, adverse event.