Table 2.
STS and EDS outcomes at week 4 by treatment in the PM+ and PM− subgroups
| Postmenopausal (PM+) (n = 242) | Not postmenopausal (PM−) (n = 207) | |||||
|---|---|---|---|---|---|---|
| Baseline | CFB | Treatment–vehicle control differencea in CFB, LSM (95% CI) | Baseline | CFB | Treatment–vehicle control differencea in CFB, LSM (95% CI) | |
| STS (mm), mean (SD) | ||||||
| OC-01 | 4.5 (2.9) | 10.6 (9.8) | 5.5 (3.3, 7.7) | 5.1 (2.7) | 13.7 (10.2) | 6.7 (4.1, 9.3) |
| Vehicle | 4.6 (2.9) | 5.5 (6.9) | 5.2 (3.0) | 7.2 (8.3) | ||
| EDS, mean (SD) | ||||||
| OC-01 | 61.8 (20.6) | − 21.0 (29.1) | − 4.1 (− 10.6, 2.5) | 57.7 (22.4) | − 18.6 (29.5) | − 5.5 (− 12.3, 1.3) |
| Vehicle | 58.8 (21.7) | − 14.7 (28.3) | 60.0 (21.5) | − 13.5 (25.1) | ||
CFB change from baseline, CI confidence interval, EDS eye dryness score, ICFS inferior corneal fluorescein staining score, LSM least-squares mean, STS Schirmer test score
aTreatment–vehicle control difference from ANCOVA models; all treatment–subgroup interaction terms in ANCOVA models were insignificant (p > 0.05)