Table 2.
Subject disposition
| Subject disposition | Combination, n (%) | 0.1% dexamethasone, n (%) | 1% azithromycin, n (%) | Vehicle, n (%) | All subjects, N (%) |
|---|---|---|---|---|---|
| Randomized (safety and intent-to-treat populations) | 305 | 298 | 155 | 149 | 907 |
| Per protocol population | 272 (89.2) | 271 (90.9) | 139 (89.7) | 139 (93.3) | 821 (90.5) |
| Completed study | 183 (60) | 187 (62.8) | 89 (57.4) | 93 (62.4) | 552 (60.9) |
| Exited early | 122 (40) | 111 (37.2) | 66 (42.6) | 56 (37.6) | 355 (39.1) |
| Reasons for exiting (during and after dosing) | |||||
| Did not reach complete clinical resolution or improvement from signs and symptoms at day 15 | 36 (11.8) | 22 (7.4) | 28 (18.1) | 23 (15.4) | 109 (12) |
| Experienced a clinical event* | 2 (0.7) | 1 (0.3) | 0 | 0 | 3 (0.3) |
| Experienced an increase in signs and symptoms after day 15 | 36 (11.8) | 46 (15.4) | 13 (8.4) | 9 (6) | 104 (11.5) |
| Adverse events | 6 (2) | 7 (2.3) | 4 (2.6) | 5 (3.4) | 22 (2.4) |
Notes:
*
Defined as a change in blepharitis score of ≥4 from the day 15 score, and had to include a score of 1 for eyelid redness and a score of 1 for eyelid irritation. Combination =0.1% dexamethasone and 1% azithromycin.