Table 5.
Clinical sign and symptom score over time (intent-to-treat population)
| Visit 4 (day 15) | Combination (n=305) | 0.1% dexamethasone (n=298) | 1% azithromycin (n=155) | Vehicle (n=149) | All subjects (N=907) |
|---|---|---|---|---|---|
| Visit 4 (day 15) | |||||
| n* | 303 | 294 | 155 | 148 | 900 |
| Mean (SD) | 3.5 (2.12) | 3.4 (1.96) | 4.2 (2.46) | 4.1 (2.45) | 3.7 (2.21) |
| Visit 5 (1 month) | |||||
| n | 248 | 255 | 111 | 113 | 727 |
| Mean (SD) | 3.3 (2.27) | 3.5 (2.08) | 3.1 (2.02) | 3.3 (1.81) | 3.3 (2.1) |
| Visit 6 (2 months) | |||||
| n | 215 | 226 | 107 | 107 | 655 |
| Mean (SD) | 2.9 (2.11) | 3.2 (2.18) | 3 (2.22) | 3.1 (2.05) | 3.1 (2.14) |
| Visit 7 (3 months) | |||||
| n | 195 | 206 | 98 | 102 | 601 |
| Mean (SD) | 2.8 (1.98) | 2.8 (1.96) | 2.4 (1.76) | 2.9 (2) | 2.8 (1.94) |
| Visit 8 (4 months) | |||||
| n | 182 | 191 | 94 | 92 | 559 |
| Mean (SD) | 2.5 (1.91) | 2.7 (1.98) | 2.5 (1.76) | 2.7 (2.11) | 2.6 (1.94) |
| Visit 9 (5 months) | |||||
| n | 186 | 189 | 87 | 93 | 555 |
| Mean (SD) | 2.4 (1.9) | 2.5 (1.87) | 2.2 (1.79) | 2.7 (1.92) | 2.5 (1.87) |
| Visit 10 (6 months) | |||||
| n | 183 | 187 | 90 | 93 | 553 |
| Mean (SD) | 2.4 (1.85) | 2.5 (1.92) | 2.3 (1.68) | 2.4 (1.88) | 2.4 (1.85) |
Notes:
*
There were seven subjects who were enrolled and received the study drug, but did not have any measurements after baseline; these seven subjects were thus not included in the analyses of changes in clinical signs and symptoms. The last observation carried forward was used for imputation of any missing data. Combination =0.1% dexamethasone and 1% azithromycin.
Abbreviation: SD, standard deviation.