TABLE 1.
Primary and Key Secondary Outcomes of Lotilaner Ophthalmic Solution 0.25% Pivotal Trials
| SATURN-1 | SATURN-2 | ||
|---|---|---|---|
| Timepoint | Clinically meaningful collarette cure (% with lotilaner vs % with vehicle)a | Timepoint | Clinically meaningful collarette cure (% with lotilaner vs % with vehicle)b |
| Day 8 | (23.2% vs 10.6%; P = 0.0003) | Day 8 | (3.6% vs 3.4%; P = 0.4622) |
| Day 15 | (40.7% vs 16.3%; P < 0.0001) | Day 15 | (18.2% vs 3.5%; P < 0.0001) |
| Day 22 | (60.4% vs 18.4%; P < 0.0001) | Day 22 | (28.2% vs 6.0%; P < 0.0001) |
| Day 43c | (81.3% vs 23.0%; P < 0.0001) | Day 43d | (56.0% vs 12.5%; P < 0.0001) |
| Timepoint | Mite eradication (mite density of 0 mites/lash) (% with lotilaner vs % with vehicle) | Timepoint | Mite eradication (mite density of 0 mites/lash) (% with lotilaner vs % with vehicle) |
| Day 43e | (67.9% vs 17.6%; P < 0.0001) | Day 43f | (51.8% vs 14.6%; P < 0.0001) |
| Timepoint | Erythema cure (grade 0) (% with lotilaner vs % with vehicle) | Timepoint | Erythema cure (grade 0) (% with lotilaner vs % with vehicle) |
| Day 43e | (19.1% vs 6.9%; P = 0.0001) | Day 43f | (31.1% vs 9.0%; P < 0.0001) |
Adapted from Yeu et al3 and Gaddie et al.4
aProportion of patients with clinically meaningful collarette cure (grade 0-1, ≤10 collarettes) in the upper eyelid of the analysis eye in the study and control groups.
bProportion of patients with collarette cure (grade 0 [0-2 lashes with collarettes]) in the upper eyelid of the analysis eye in the study and control groups.
cPrimary endpoint.
dPrimary endpoint.
eSecondary endpoint.
fSecondary endpoint.