Table 6.
Percentage of Patients Improving on Day 42 (Double-Masked Treatment Phase) and Day 91 (Open-Label Rollover Phase), by Treatment Group
| Parameter | Vehicle Control (N = 22) n (%) | Day 42 FD hPL 10% (N = 20) n (%) | Day 42 FD hPL 30% (N = 22) n (%) | Rollover (Day 91) FD hPL 30% (N = 17) n (%) |
|---|---|---|---|---|
| Corneal fluorescein stain | 10 (45.5%) | 12 (60.0%) | 7 (31.8%) | 10 (58.5%) |
| Corneal lissamine green | 12 (54.5%) | 13 (65.0%) | 10 (45.5%) | 8 (47.1%) |
| Total OSDI score | 15 (68.2%) | 16 (80.0%) | 14 (63.6%) | 10 (58.8%) |
| Tear osmolarity | 5 (22.7%) | 6 (30.0%) | 7 (31.8%) | 6 (35.3%) |
| Schirmer’s test | 9 (40.9%) | 9 (45.0%) | 6 (27.3%) | 7 (41.2%) |
| Investigator’s global examination | 6 (27.3%) | 13 (65.0%) | 16 (72.7%) | 11 (64.7%) |
| TBUT | 12 (54.5%) | 10 (50.0%) | 13 (59.1%) | 8 (47.1%) |
| Eye discomfort | 13 (59.1%) | 15 (75.0%) | 17 (77.3%) | 10 (58.8%) |
| Symptom frequency | ||||
| Burning/stinging | 14 (63.6%) | 10 (50.0%) | 13 (59.1%) | 11 (64.7%) |
| Itching | 12 (54.5%) | 10 (50.0%) | 16 (72.7%) | 10 (58.8%) |
| Foreign body | 11 (50.0%) | 15 (75.0%) | 12 (54.5%) | 7 (41.2%) |
| Eye discomfort | 15 (68.2%) | 14 (70.0%) | 20 (90.9%) | 13 (76.5%) |
| Eye dryness | 11 (50.0%) | 14 (70.0%) | 15 (68.2%) | 12 (70.6%) |
| Photophobia | 10 (45.5%) | 13 (65.0%) | 15 (68.2%) | 9 (52.9%) |
| Pain | 13 (59.1%) | 12 (60.0%) | 13 (59.1%) | 9 (52.9%) |
| Grittiness | 12 (54.5%) | 9 (45.0%) | 14 (63.6%) | 9 (52.9%) |
For the double-masked phase, N = the number of patients randomized in a specific treatment group, and for the open-label phase, N = the number of patients planned to be enrolled in this group; n = number of patients with data available; calculation of percentages based on N; OSDI = Ocular Surface Disease Index; TBUT = tear breakup time.