Table 1.
Baseline characteristics and subject demographics
| Characteristics | Pharmacokinetic study* (N=36)
|
Safety study** (N=499)
|
||
|---|---|---|---|---|
| Olopatadine 0.77% (n=24) | Vehicle (n=12) | Olopatadine 0.77% (n=330) | Vehicle (n=169) | |
| Age (years) | ||||
| Mean (SD) | 42.0 (11.7) | 42.8 (12.9) | 32.4 (17.1) | 31.5 (15.7) |
| 2–17, n (%) | 0 | 0 | 51 (15.5) | 24 (14.2) |
| ≥18, n (%) | 24 (100.0) | 12 (100.0) | 279 (84.5) | 145 (85.8) |
| Sex, n (%) | ||||
| Female | 10 (41.7) | 7 (58.3) | 214 (64.8) | 111 (65.7) |
| Male | 14 (58.3) | 5 (41.7) | 116 (35.2) | 58 (34.3) |
| Race, n (%) | ||||
| Asian | 14 (58.3) | 6 (50.0) | 12 (3.6) | 4 (2.4) |
| Black or African American | 2 (8.3) | 1 (8.3) | 20 (6.1) | 17 (10.1) |
| White | 7 (29.2) | 5 (41.7) | 289 (87.6) | 140 (82.8) |
| Multi-racial | 1 (4.2) | 0 | 4 (1.2) | 3 (1.8) |
| Others# | 0 | 0 | 5 (1.5) | 5 (3.0) |
| Iris color, n (%) | ||||
| Blue | 1 (4.2) | 0 | 86 (26.1) | 29 (17.2) |
| Brown | 21 (87.5) | 11 (91.7) | 169 (51.2) | 93 (55.0) |
| Green | 1 (4.2) | 0 | 26 (7.9) | 18 (10.7) |
| Hazel | 1 (4.2) | 1 (8.3) | 45 (13.6) | 29 (17.2) |
| Gray | 0 | 0 | 4 (1.2) | 0 |
| Contact lens use, n (%) | NA | NA | 51 (15.5) | 24 (14.2) |
Notes:
*
Pharmacokinetic population included subjects who were exposed to any dose of the test article.
**
Safety population included subjects who were exposed to the test article for the duration of 6 weeks.
#
Native Hawaiian or other Pacific Islander (n=3), American Indian or Alaskan Native (n=1), others (n=6). Olopatadine 0.77%, olopatadine hydrochloride solution 0.77%; vehicle, olopatadine hydrochloride solution 0.77% vehicle.
Abbreviations: NA, not analyzed; SD, standard deviation.