Table 1. Patient characteristics (safety population).
| Characteristic, n (%) | Difluprednate 0.05% (n=39) | Prednisolone acetate 1% (n=40) |
|---|---|---|
| Age | ||
| 0–27 Days | 3 (7.7) | 3 (7.5) |
| 28 Days–23 months | 28 (71.8) | 26 (65.0) |
| 24 Months–47 monthsa | 8 (20.5) | 11 (27.5) |
| Sex | ||
| Male | 17 (43.6) | 20 (50.0) |
| Female | 22 (56.4) | 20 (50.0) |
| Ethnicity | ||
| Hispanic, Latino, or Spanish | 9 (23.1) | 8 (20.0) |
| Other | 30 (76.9) | 32 (80.0) |
| Race | ||
| White | 21 (53.8) | 24 (60.0) |
| Black or African American | 9 (23.1) | 9 (22.5) |
| Asian | 0 (0.0) | 1 (2.5) |
| Multi-racial | 3 (7.7) | 2 (5.0) |
| Other | 6 (15.4) | 4 (10.0) |
| Iris colour | ||
| Brown | 22 (56.4) | 22 (55.0) |
| Green | 0 (0.0) | 1 (2.5) |
| Blue | 15 (38.5) | 16 (40.0) |
| Grey | 1 (2.6) | 0 (0.0) |
| Other | 1 (2.6) | 1 (2.5) |
a
The 24–47-month category included all patients who had reached their second birthdays even if they had reached their third birthday. Hence, some patients reached 47 months.