Table 3. Treatment-Emergent Adverse Events Reported in >2% of Participants in Either Treatment Group.
| System organ class preferred term | No. (%) | |
|---|---|---|
| AGN-190584 (n = 163) | Vehicle (n = 159) | |
| Eye disorders | ||
| Visual impairment | 7 (4.3) | 1 (0.6) |
| Conjunctival hyperemia | 4 (2.5) | 4 (2.5) |
| Vision blur | 4 (2.5) | 2 (1.3) |
| Eye irritation | 4 (2.5) | 1 (0.6) |
| Eye pain | 4 (2.5) | 1 (0.6) |
| Lacrimation increased | 4 (2.5) | 0 |
| Punctate keratitis | 1 (0.6) | 5 (3.1) |
| Nervous system disorders | ||
| Headachea | 23 (14.1) | 15 (9.4) |
| Gastrointestinal disorders | ||
| Nausea | 4 (2.5) | 0 |
a
Participants were asked to provide a subjective rating of temporal/supraorbital headaches using a visual analog scale, which may have prompted reports of headaches as an adverse event.