Table 5.
Signs and Symptoms of Dry Eye: Comparison of Change from Baseline to Day 42 Between Treatments in the Double-Masked Treatment Phase
| Parameter | Statistic | Vehicle Control (N = 22) | FD hPL 10% (N = 20) | FD hPL 30% (N = 22) | FD hPL 10%–Vehicle Control | FD hPL 30%-Vehicle Control |
|---|---|---|---|---|---|---|
| Tear film breakup time | Mean | −0.27 | 0.00 | 1.03 | 0.27 | 1.30 |
| 95% CI | (−1.76, 1.23) | (−1.37, 1.37) | (−0.48, 2.55) | (−1.23, 1.77) | (−0.17, 2.77) | |
| P value† | 0.721 | 0.082 | ||||
| Investigator’s global examination | Mean | 4.52 | 3.47 | 3.66 | −1.05 | −0.86 |
| 95% CI | (3.65, 5.39) | (2.66, 4.28) | (2.78, 4.54) | (−1.94, −0.16) | (−1.72, 0.01) | |
| P value† | 0.022 | 0.052 | ||||
| Tear osmolarity | Mean | −10.83 | −14.86 | −19.71 | −4.03 | −8.88 |
| 95% CI | (−22.22, 0.57) | (−25.32, −4.39) | (−31.28, −8.14) | (−15.32, 7.27) | (−19.98, 2.21) | |
| P value† | 0.478 | 0.114 | ||||
| Ocular discomfort | Mean | −2.70 | −11.44 | −20.73 | −8.74 | −18.04 |
| 95% CI | (−18.69, 13.29) | (−26.38, 3.51) | (−36.98, −4.49) | (−25.83, 8.36) | (−34.83, −1.25) | |
| P value† | 0.311 | 0.036 | ||||
| OSDI | Mean | −10.83 | −14.86 | −19.71 | −4.03 | −8.88 |
| 95% CI | (−22.22, 0.57) | (−25.32, −4.39) | (−31.28, −8.14) | (−15.32, 7.27) | (−19.98, 2.21) | |
| P value† | 0.478 | 0.114 | ||||
| Lissamine green staining score | Mean | −2.11 | −1.43 | −1.29 | 0.67 | 0.82 |
| 95% CI | (−5.5-, 1.29) | (−4.59, 1.72) | (−4.74, 2.16) | (−2.86, 4.21) | (−2.66, 4.29) | |
| P value† | 0.705 | 0.640 | ||||
| Fluorescein sodium staining score | Mean | −0.34 | −0.48 | 0.96 | −0.14 | 1.30 |
| 95% CI | (−1.58, 0.90) | (−1.65, 0.68) | (−0.30, 2.22) | (−1.48, 1.20) | (−0.01, 2.62) | |
| P value† | 0.833 | 0.052 | ||||
| Schirmer’s Test | Mean | −0.19 | 1.24 | −0.81 | 1.42 | −0.62 |
| 95% CI | (−2.30, 1.93) | (−0.75, 3.22) | (−2.96, 1.34) | (−0.85, 3.70) | (−2.86, 1.62) | |
| P value† | 0.216 | 0.581 |
CI = confidence interval; FD hPL = fibrinogen-depleted human platelet lysate; N = number of patients in a specific group; OSDI = Ocular Surface Disease Index.
Baseline is defined as the last available value prior to the administration of the study drug.
The means, mean differences, confidence intervals, and P values are from a repeated measures model with treatment group, baseline severity category, visit, and treatment-by-visit interaction as fixed categorical effects using an unstructured covariance matrix.
The confidence intervals and P values are for mean change from baseline in comparison to the vehicle.
P values are 2-sided and bolded.