[Translation] A randomized, controlled, multicenter, double-blind, parallel Phase III trial in China to evaluate the efficacy and safety of Lotilaner eye drops in the treatment of Demodex blepharitis, and an open-label pharmacokinetic substudy
主研究:
主要目的:证明0.25% Lotilaner滴眼液消除睑缘袖套状分泌物和根除蠕形螨的疗效;证明0.25% Lotilaner滴眼液在治疗蠕形螨睑缘炎中的安全性
次要目的:证明0.25% Lotilaner滴眼液消除睑缘袖套状分泌物和充血的疗效;评价眼部局部给予0.25% Lotilaner滴眼液后Lotilaner 的血药浓度
三级目的:证明每次随访访视时0.25% Lotilaner滴眼液对分析眼上眼睑平均袖套状分泌物评分和分析眼平均螨虫密度较基线降低的疗效;确定0.25% Lotilaner滴眼液在螨虫密度改善和袖套状分泌物评分降低方面的应答率
药代动力学子研究:
目的:评价眼部局部给予单次和多次0.25% Lotilaner滴眼液后Lotilaner的PK;评价0.25% Lotilaner滴眼液的安全性
[Translation] Main study:
Main objectives: To prove the efficacy of 0.25% Lotilaner eye drops in eliminating eyelid cuff discharge and eradicating Demodex mites; to prove the safety of 0.25% Lotilaner eye drops in the treatment of Demodex blepharitis
Secondary objectives: To demonstrate the efficacy of 0.25% Lotilaner eye drops in eliminating eyelid cuff discharge and congestion; to evaluate the blood levels of Lotilaner after topical ocular administration of 0.25% Lotilaner eye drops
Tertiary Objective: To demonstrate the efficacy of 0.25% Lotilaner eye drops at each follow-up visit on the analysis of eye upper eyelid mean cuff discharge score and analysis of eye mean mite density reduction from baseline; to determine the effect of 0.25% Lotilaner eye drops on mites Response Rates for Density Improvement and Sleeve Score Reduction
Pharmacokinetic sub-study:
Objective: To evaluate the PK of Lotilaner after single and multiple administration of 0.25% Lotilaner eye drops to the eye; to evaluate the safety of 0.25% Lotilaner eye drops