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AEs in the per-protocol population
| AEs | Placebo (N=70) | BBOS 1.5% (N=70) |
|---|---|---|
| Total AEs | 10 | 24 |
| AEs considered related to test agent | 3 | 8 |
| Ocular AEs | ||
| Eye irritation | 2 | 3 |
| Foreign body sensation | 1 | 0 |
| Conjunctival cyst | 0 | 1a |
| Trace SPK | 0 | 1a |
Note:
Adverse event considered unrelated to instillation of test agent.
Abbreviations: AE, adverse event; BBOS, bepotastine besilate ophthalmic solution 1.5%; N, number of subjects; SPK, superficial punctate keratitis.
