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. 2024 Oct;30(10-a Suppl):S1–S8. doi: 10.18553/jmcp.2024.30.10-a.s1

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.