TABLE 2.
STS in the Study Eye at Day 28 (Primary End Point)
| OC-01 | ||||
| 0.006 mg (n = 47) | 0.03 mg (n = 48) | 0.06 mg (n = 44) | Vehicle (n = 43) | |
| Mean change from baseline (mm) | ||||
| No. | 47 | 46 | 40 | 43 |
| Mean (SD) | 10.0 (9.5) | 11.8 (8.9) | 11.4 (9.3) | 3.2 (5.6) |
| Range (min to max) | −5 to 34 | −2 to 29 | −3 to 31 | −4 to 26 |
| Quartiles (25th, median, 75th) | 3, 7, 15 | 5, 10, 15 | 5, 8, 19 | 0, 2, 5 |
| LS mean change from baseline | ||||
| LS mean (SE) [95% CI] | 10.1 (1.2) [7.7–12.5] | 11.4 (1.3) [8.9–13.9] | 11.1 (1.3) [8.5–13.7] | 3.7 (1.3) [1.1–6.2] |
| Treatment comparisons | ||||
| LS mean difference (SE) [95% CI]* | 6.4 (1.8) | 7.7 (1.8) [3.8–11.7] | 7.5 (1.9) [3.4–11.6] | — |
| P† | <0.001 | <0.001 | — | |
Dunnett-corrected 95% CIs.
ANCOVA P value was calculated using a model with baseline STS (study eye), baseline STS with a cotton swab nasal stimulation (study eye), and study sites as covariates.
max, maximum; min, minimum; SE, standard error.