Table 5.
AEs in ≥ 1.0% of patients in any group (safety population)
| System organ class preferred term |
Number (%) of patients | ||
|---|---|---|---|
| Netarsudil 0.02% QD N = 122 |
Ripasudil 0.4% BID N = 123 |
p valuea | |
| Eye disorders | 73 (59.8) | 80 (65.0) | 0.4302 |
| Conjunctival hyperemia | 67 (54.9) | 77 (62.6) | 0.2441 |
| Eye irritation | 7 (5.7) | 7 (5.7) | > 0.9999 |
| Conjunctival hemorrhage | 6 (4.9) | 0 | 0.0143 |
| Visual acuity reduced | 3 (2.5) | 0 | 0.1219 |
| Conjunctival oedema | 2 (1.6) | 0 | 0.2469 |
| Cornea verticillata | 2 (1.6) | 0 | 0.2469 |
| Eye discharge | 2 (1.6) | 0 | 0.2469 |
| Eye pruritus | 2 (1.6) | 2 (1.6) | > 0.9999 |
| Punctate keratitis | 2 (1.6) | 1 (0.8) | 0.6219 |
| Vision blurred | 2 (1.6) | 0 | 0.2469 |
When reporting incidence, a patient was counted once if they ever experienced an event within the system organ class or individual preferred term more than once
AEs were coded using Medical Dictionary for Regulatory Activities, in Japanese (MedDRA/J), v.23.1
AE adverse events, BID twice a day, N number of patients in the given treatment of safety population, QD once a day
Percentages are based on the number of patients (N) in the given treatment group for the safety population
ap values are from Fisher’s exact test comparing the incidence between netarsudil 0.02% and ripasudil 0.4%