NextPharma Oy

Main study: Primary objective: To demonstrate the efficacy of 0.25% Lotilaner eye drops in eliminating eyelid cuffing and eradicating Demodex; To demonstrate the safety of 0.25% Lotilaner eye drops in the treatment of Demodex blepharitis Secondary objective: To demonstrate the efficacy of 0.25% Lotilaner eye drops in eliminating eyelid cuffing and congestion; To evaluate the plasma concentration of Lotilaner after topical administration of 0.25% Lotilaner eye drops Tertiary objective: To demonstrate the efficacy of 0.25% Lotilaner eye drops in reducing the average upper eyelid cuffing score and average mite density of the analyzed eye at each follow-up visit compared with baseline; To determine the response rate of 0.25% Lotilaner eye drops in improving mite density and reducing cuffing scores Pharmacokinetic sub-study: Objective: To evaluate the PK of Lotilaner after single and multiple topical administration of 0.25% Lotilaner eye drops; To evaluate the 0.25% Safety of Lotilaner Eye Drops