Table 2.
Primary and secondary efficacy variables at each study visit (ITT population)
| Variables at study visits | Group A (n = 23) | Group B (n = 22) | p value |
|---|---|---|---|
| TBUT—mean ± SD | |||
| Visit − 1 | 8.5 ± 1.8 | 7.8 ± 0.7 | 0.11 |
| Visit 0 | 8.4 ± 1.8 | 7.2 ± 0.9 | 0.01 |
| Visit 1 | 7.4 ± 1.5 | 6.0 ± 1.3 | 0.002 |
| Visit 2 | 7.9 ± 1.6 | 6.0 ± 1.5 | 0.0002 |
| OSDI Questionnaire Score—mean ± SD | |||
| Visit − 1 | 13 ± 8 | 14 ± 8 | 0.55 |
| Visit 0 | 6 ± 5 | 11 ± 7 | 0.01 |
| Visit 1 | 8 ± 7 | 16 ± 12 | 0.014 |
| Visit 2 | 9 ± 8 | 16 ± 11 | 0.027 |
| Osmolimetry test—mean ± SD | |||
| Visit − 1 | 305 ± 17 | 303 ± 13 | 0.77 |
| Visit 0 | 306 ± 17 | 299 ± 17 | 0.21 |
| Visit 1 | 302 ± 18 | 304 ± 17 | 0.79 |
| Visit 2 | 304 ± 16 | 302 ± 13 | 0.66 |
| Schirmer I test—mean ± SD | |||
| Visit − 1 | 20 ± 6 | 18 ± 5 | 0.31 |
| Visit 0 | 20 ± 7 | 16 ± 5 | 0.08 |
| Visit 1 | 16 ± 6 | 16 ± 8 | 0.84 |
| Visit 2 | 18 ± 8 | 16 ± 7 | 0.52 |
| Staining grade with fluorescein—n (%) | |||
| Visit 1 | |||
| 0 | 18 (78.3%) | 13 (59.1%) | |
| 1 | 4 (17.4%) | 5 (22.7%) | |
| 2 | 1 (4.3%) | 4 (18.2%) | |
| Visit 2 | |||
| 0 | 15 (65.2%) | 12 (54.5%) | |
| 1 | 7 (30.4%) | 5 (22.7%) | |
| 2 | 1 (4.3%) | 5 (22.7%) | |
Visit − 1 screening; Visit 0 baseline; Visit 1 week 1; Visit 2 week 2