Table 2.
Baseline Ocular Assessments by Treatment Group
| Assessment | Vehicle Control (N = 22) | FD hPL 10% (N = 20) | FD hPL 30% (N = 22) |
|---|---|---|---|
| Artificial tear use | 22 (100%) | 20 (100%) | 22 (100%) |
| Symptom frequency (mean ± SD) | |||
| Burning/stinging | 48.3 (±27.9) | 44.9 (±33.8) | 50.8 (±37.1) |
| Eye discomfort | 61.5 (±27.9) | 60.2 (±29.6) | 73.4 (±27.5) |
| Eye dryness | 76.9 (±24.1) | 74.4 (±25.4) | 77.5 (±28.3) |
| Foreign body | 36.5 (±31.5) | 44.3 (±31.5) | 46.5 (±34.4) |
| Grittiness | 41.9 (±33.4) | 36.0 (35.05) | 47.7 (32.87) |
| Itching | 47.3 (31.37) | 30.1 (24.81) | 44.1 (31.51) |
| Pain | 39.4 (29.67) | 36.8 (30.35) | 37.6 (34.88) |
| Photophobia | 49.5 (31.12) | 54.5 (31.72) | 71.6 (35.97) |
| Ocular discomfort | 61.4 (20.69) | 60.5 (24.53) | 70.3 (25.09) |
| Fluorescein sodium staining | 3.6 (2.75) | 4.3 (2.15) | 4.0 (1.90) |
| Total lissamine green staining | 9.8 (5.83) | 10.2 (6.64) | 12.1 (4.20) |
| Tear osmolarity | 294.62 (23.948) | 292.61 (40.033) | 314.13 (21.273) |
| Schirmer’s test | 3.16 (3.057) | 3.43 (4.482) | 2.95 (2.355) |
| Investigator’s global examination | 4.41 (1.008) | 4.85 (0.366) | 4.57 (0.904) |
AE = adverse event; m = number of events; N = number of patients in a specific group; n = number of patients with a particular AE; calculation of percentages based on N.
Treatment-emergent AEs are defined as AEs that increased in severity or newly developed after first dosing.
FD hPL = fibrinogen-depleted human platelet lysate; SD = standard deviation.