Table 3.
Summary of efficacy results (pooled ITT populations)
| KPI-121 1% BID (n=386) | Vehiclea (n=385) | P-valueb | |
|---|---|---|---|
|
| |||
| Primary endpoints, n (%) | |||
| Complete resolution of anterior chamber cells at Day 8 maintained through Day 15 with no rescue medication prior to Day 15 | 93 (24.1) | 51 (13.2) | 0.0001 |
| Complete resolution of ocular pain at Day 8 maintained through Day 15 with no rescue medication prior to Day 15 | 216 (56.0) | 139 (36.1) | <0.0001 |
| Key non-primary endpoints, n (%) | |||
| Complete resolution of pain at Day 4 maintained through Day 15 with no rescue medication prior to Day 15 | 164 (42.5) | 96 (24.9) | <0.0001 |
| Complete resolution of anterior chamber cells at Day 15 with no rescue medication prior to Day 15c | 193 (50.0) | 102 (26.5) | <0.0001 |
| Complete resolution of pain at Day 15 with no rescue medication prior to Day 15c | 268 (69.4) | 186 (48.3) | <0.0001 |
Notes:
a
In Trial 1, the two vehicle groups (vehicle A [QID] and vehicle B [BID]) were pooled for all analyses. This pooled vehicle group comprised both vehicle groups from Trial 1 and one vehicle group (dosed BID) in Trial 2.
b
P-values are based on two-sided chi-squared tests, unadjusted, wherein the significance level was 0.05.
c
Subjects with missing scores at Day 15 were counted as nonresponders for the Day 15 analyses. Complete resolution = grade 0, for all scales. A subject was not considered to have been rescued if rescue medication started on the Day 15 visit date.
Abbreviations: BID, twice daily; ITT, intent to treat; QID, four times daily.