Table 4.
Change of total symptom and sign scores after administration (ITT/PP dataset)
Variables | ITT | PP | ||||||
---|---|---|---|---|---|---|---|---|
|
|
|||||||
Treatment groupa | Control groupb | F-value | P-value | Treatment groupa | Control groupb | F-value | P-value | |
Baseline | ||||||||
TSI, mean ± SD | 17.75 ± 5.71 | 17.98 ± 5.45 | 0.1726 | 0.6782 | 17.86 ± 5.80 | 17.91 ± 5.52 | 0.02 | 0.8983 |
Visit 1 (3rd day), mean ± SD | ||||||||
TSI | 14.19 ± 5.80 | 14.03 ± 5.11 | 0.0155 | 0.9009 | 14.25 ± 5.92 | 13.82 ± 5.15 | 0.21 | 0.6447 |
DTB | 3.56 ± 3.51 | 3.95 ± 4.03 | 0.5795 | 0.4473 | 3.61 ± 3.59 | 4.09 ± 3.86 | 0.67 | 0.4147 |
Visit 2 (7th day), mean ± SD | ||||||||
TSI | 9.91 ± 5.08 | 9.90 ± 4.77 | 0.0093 | 0.9231 | 9.75 ± 5.16 | 9.41 ± 4.40 | 0.12 | 0.7279 |
DTB | 7.84 ± 4.72 | 8.08 ± 5.27 | 0.1318 | 0.7169 | 8.11 ± 4.69 | 8.50 ± 4.87 | 0.22 | 0.6420 |
Visit 3 (14th day), mean ± SD | ||||||||
TSI | 5.71 ± 4.31 | 6.06 ± 4.91 | 0.4706 | 0.4935 | 5.41 ± 4.16 | 5.30 ± 3.98 | 0.04 | 0.8329 |
DTB | 12.04 ± 5.58 | 11.92 ± 5.97 | 0.0114 | 0.9153 | 12.45 ± 5.33 | 12.61 ± 5.37 | 0.00 | 0.9945 |
Visit 4 (21st day), mean ± SD | ||||||||
TSI | 2.50 ± 3.32 | 3.16 ± 4.80 | 2.24 | 0.1361 | 2.06 ± 2.71 | 2.32 ± 3.09 | 0.70 | 0.4033 |
DTB | 15.25 ± 6.05 | 14.82 ± 6.57 | 0.19 | 0.6609 | 15.80 ± 5.59 | 15.59 ± 5.78 | 0.08 | 0.7771 |
Notes:
Treatment group = ganciclovir in situ ophthalmic gel group;
control group = ganciclovir ophthalmic gel group.
Abbreviations: ITT, intent-to-treat; PP, per-protocol; TSI, total scores of clinical indicators; SD, standard deviation; DTB, decrease of total scores of clinical indicators from baseline.