Table 3.
Ocular Treatment-Emergent Adverse Events ≥5% in at Least One Group
| Prior Latanoprost BAK-Free (n = 80) | Prior Reference (n = 81) | Total (N = 161) | ||||
|---|---|---|---|---|---|---|
| Patient | Incidence | Patient | Incidence | Patient | Incidence | |
| Any TEAE | 66 (82.5) | 849 | 74 (91.4) | 791 | 140 (87.0) | 1640 |
| Eye pain | 40 (50.0) | 596 | 52 (64.2) | 437 | 92 (57.1) | 1033 |
| Ocular hyperemia | 38 (47.5) | 151 | 44 (54.3) | 168 | 82 (50.9) | 319 |
| Growth of eyelashes | 17 (21.3) | 19 | 19 (23.5) | 26 | 36 (22.4) | 45 |
| Eyelash thickening | 15 (18.8) | 18 | 16 (19.8) | 26 | 31 (19.3) | 44 |
| Eye discharge | 6 (7.5) | 19 | 13 (16.0) | 70 | 19 (11.8) | 89 |
| Conjunctival hyperemia | 4 (5.0) | 5 | 6 (7.4) | 9 | 10 (6.2) | 14 |
| Erythema of eyelid | 5 (6.3) | 9 | 4 (4.9) | 4 | 9 (5.6) | 13 |
| Punctate keratitis | 0 | 0 | 5 (6.2) | 8 | 5 (3.1) | 8 |
Notes: Data shown as n (%) for the safety population (all patients who took ≥1 dose of study drug). TEAEs are listed per the MedDRA preferred term.
Abbreviations: AE, adverse event; BAK, benzalkonium chloride; MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent AE.