Table 4.
Primary Efficacy Endpoints for the Intent-to-Treat Population
| Visit | Placebo (n = 80) | PL9643 (n = 80) |
|---|---|---|
| Inferior corneal staining | ||
| Baseline | ||
| Mean (SD) | 1.45 (0.537) | 1.42 (0.524) |
| 95% CI | 1.33 to 1.57 | 1.30 to 1.54 |
| Week 12 | ||
| Mean (SD) | 0.77 (0.885) | 0.65 (0.895) |
| 95% CI | 0.58 to 0.96 | 0.46 to 0.85 |
| Change from baseline to week 12 | ||
| LS mean (SE) | –0.67 (0.100) | –0.78 (0.098) |
| 95% CI | –0.86 to −0.47 | –0.97 to −0.58 |
| PL9643 vs. placebo | ||
| LS mean difference (SE) | –0.11 (0.139) | |
| 95% CI | –0.38 to 0.16 (P = 0.4363) | |
| Ocular discomfort | ||
| Baseline | ||
| Mean (SD) | 2.4 (0.93) | –0.6 (1.18) |
| 95% CI | 2.2 to 2.6 | –0.8 to −0.3 |
| Week 12 | ||
| Mean (SD) | 1.8 (1.18) | –0.5 (0.12) |
| 95% CI | 1.6 to 2.1 | –0.8 to −0.3 |
| Change from baseline to week 12 | ||
| LS mean (SE) | –0.6 (0.12) | –0.5 (0.12) |
| 95% CI | –0.8 to −0.3 | –0.8 to −0.3 |
| PL9643 vs. placebo | ||
| LS mean difference (SE) | 0 (0.16) | |
| 95% CI | –0.3 to 0.4 (P = 0.8360) | |
95% CI, 95% confidence interval; LS, least squares; SE, standard error.