Table 2.
Demographics for per-protocol population
| BBOS 1.5% (N=70) | Placebo (N=70) | All subjects (N=140) | |
|---|---|---|---|
| Age (years) | |||
| Mean (SD) | 38.3 (16.9) | 37.1 (13.5) | 37.7 (15.2) |
| Median | 39 | 39 | 39 |
| Min–max | 11–73 | 13–65 | 11–73 |
| P-valuea | 0.644 | ||
| Sex, N (%) | |||
| Female | 35 (50.0) | 41 (58.6) | 76 (54.3) |
| Male | 35 (50.0) | 29 (41.4) | 64 (45.7) |
| P-valueb | 0.396 | ||
| Ethnicity, N (%) | |||
| Hispanic | 3 (4.3) | 4 (5.7) | 7 (5.0) |
| Non-hispanic | 67 (95.7) | 66 (94.3) | 133 (95.0) |
| P-valueb | 1.000 | ||
| Race, N (%) | |||
| African American | 5 (7.2) | 5 (7.2) | 10 (7.1) |
| American Indian or Alaska Native | 0 (0.0) | 0.0 (0) | 0 (0.0) |
| Asian | 6 (8.6) | 6 (8.6) | 12 (8.6) |
| Caucasian | 57 (81.4) | 59 (84.3) | 116 (82.9) |
| Other | 2 (2.9) | 0 (0.0) | 2 (1.4) |
| P-valueb | 0.753 | ||
| Iris color,c n (%) | (n=140) | (n=140) | (n=140) |
| Blue | 54 (38.6) | 44 (31.4) | 98 (35.0) |
| Brown | 58 (41.4) | 70 (50.0) | 128 (45.7) |
| Green | 12 (8.6) | 12 (8.6) | 24 (8.6) |
| Hazel | 16 (11.4) | 12 (8.6) | 28 (10.0) |
| Other | 0 (0.0) | 2 (1.4) | 2 (0.7) |
| P-valueb | 0.347 | ||
Notes:
a
P-value calculated using two-sample t-test comparing BBOS 1.5% to placebo.
b
P-value calculated using Fisher’s exact test comparing BBOS 1.5% to placebo.
c
Values and percentages based upon number of eyes.
Abbreviations: BBOS, bepotastine besilate ophthalmic solution; min–max, minimum–maximum; N, number of subjects; n, number of eyes; SD, standard deviation.