Table 4.
Ocular Symptom Frequency VAS: 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 |
|---|---|---|---|---|---|---|
| Burning/stinging | Mean | −6.39 | −4.98 | −26.62 | 1.41 | −20.23 |
| 95% CI | (−25.24, 12.46) | (−22.61, 12.66) | (−45.77, −7.46) | (−18.68, 21.51) | (−39.97, −0.48) | |
| P value† | 0.888 | 0.045 | ||||
| Itching | Mean | −12.31 | −7.18 | −21.67 | 5.13 | −9.36 |
| 95% CI | (−28.83, 4.21) | (−22.31, 7.96) | (−38.43, −4.91) | (−11.30, 21.57) | (−25.48, 6.76) | |
| P value† | 0.534 | 0.250 | ||||
| Foreign body | Mean | 6.45 | −10.23 | −4.61 | −16.68 | −11.05 |
| 95% CI | (−12.53, 25.43) | (−27.90, 7.43) | (−23.88, 14.67) | (−36.59, 3.22) | (−30.61, 8.50) | |
| P value† | 0.099 | 0.262 | ||||
| Eye discomfort | Mean | 2.77 | −13.19 | −30.20 | −15.96 | −32.97 |
| 95% CI | (−15.10, 20.65) | (−29.63, 3.25) | (−48.34, −12.06) | (−33.90, 1.97) | (−50.58, −15.37) | |
| P value† | 0.080 | <0.001 | ||||
| Eye dryness | Mean | −4.32 | −14.17 | −25.92 | −9.86 | −21.61 |
| 95% CI | (−25.37, 16.74) | (−33.49, 5.15) | (−47.29, −4.55) | (−30.86, 11.15) | (−42.22, −0.99) | |
| P value† | 0.352 | 0.040 | ||||
| Photophobia | Mean | −11.20 | −20.49 | −35.53 | −9.30 | −24.33 |
| 95% CI | (−33.73, 11.34) | (−40.98, −0.00) | (−58.38, −12.67) | (−30.95, 12.36) | (−45.57, −3.09) | |
| P value† | 0.394 | 0.025 | ||||
| Pain | Mean | −1.86 | −6.48 | −16.97 | −4.63 | −15.12 |
| 95% CI | (−19.13, 15.42) | (−22.49, 9.53) | (−34.51, 0.57) | (−22.43, 13.18) | (−32.61, 2.37) | |
| P value† | 0.605 | 0.089 | ||||
| Grittiness | Mean | 6.02 | 0.66 | −14.06 | −5.35 | −20.08 |
| 95% CI | (−12.66, 24.69) | (−16.81, 18.14) | (−32.77, 4.66) | (−25.09, 14.38) | (−38.88, −1.28) | |
| P value† | 0.589 | 0.037 |
CI = confidence interval; FD hPL = fibrinogen-depleted human platelet lysate; N = number of patients in a specific group; VAS = Visual Analog Scale.
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 bolded.
P values are 2-sided.