Table 2.
Proportion of patients with complete resolution of ACC, flare, ACC and flare combined, and grade 0 (no) pain on postoperative days 3–18 (ITT population)
| Day (visits) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
||||||||||||
| Day 3 (visit 4) | Day 8 (visit 5) | Day 15 (visit 6) | Day 18 (visit 7) | |||||||||
|
|
|
|
|
|||||||||
| LE gel n = 206 n (%) |
Vehicle n = 201 n (%) |
Difference (95% CI) P-value |
LE gel n = 206 n (%) |
Vehicle n = 201 n (%) |
Difference (95% CI) P-value |
LE gel n = 206 n (%) |
Vehicle n = 201 n (%) |
Difference (95% CI) P-value |
LE gel n = 206 n (%) |
Vehicle n = 201 n (%) |
Difference (95% CI) P-value |
|
| Complete resolution of ACC2 | 8 (3.9%) | 7 (3.5%) | 0.4% (−3.7%, 4.6%) 0.830 |
64 (31.1%) | 28 (13.9%) | 17.1% (8.7%, 25.6%) <0.001 |
116 (56.3%) | 61 (30.3%) | 26.0% (16.2%, 35.7%) <0.001 |
114 (55.3%) | 59 (29.4%) | 26.0% (16.2%, 35.7%) <0.001 |
| Complete resolution of flare | 93 (45.1%) | 64 (31.8%) | 13.3% (3.5%, 23.2%) 0.006 |
134 (65.0%) | 72 (35.8%) | 29.2% (19.4%, 39.0%) <0.001 |
162 (78.6%) | 90 (44.8%) | 33.9% (24.5%, 43.2%) <0.001 |
143 (69.4%) | 75 (37.3%) | 32.1% (22.4%, 41.8%) <0.001 |
| Complete resolution of ACC and flare | 6 (2.9%) | 6 (3.0%) | −0.1% (−3.9%, 3.7%) 0.966 |
63 (30.6%) | 23 (11.4%) | 19.1% (11.0%, 27.3%) ≤0.001 |
115 (55.8%) | 57 (28.4%) | 27.5% (17.8%, 37.2%) <0.001 |
113 (54.9%) | 57 (28.4%) | 26.5% (16.8%, 36.2%) <0.001 |
| Grade 0 (no) pain | 139 (67.5%) | 93 (46.3%) | 21.2% (11.3%, 31.1%) <0.001 |
156 (75.7%) | 92 (45.8%) | 30.0% (20.4%, 39.5%) <0.001 |
160 (77.7%) | 89 (44.3%) | 33.4% (24.0%, 42.8%) <0.001 |
151 (73.3%) | 79 (39.3%) | 34.0% (24.4%, 43.5%) <0.001 |
Note: Primary end points are shaded in gray.
Abbreviations: LE, loteprednol etabonate; ACC, anterior chamber cell; CI, confidence interval; ITT, intention-to-treat.