Abstract：
To evaluate the safety and efficacy of lotilaner ophthalmic solution 0.25% compared with vehicle for the treatment of Demodex blepharitis.
Prospective, randomized, double-masked, vehicle-controlled, multicenter, phase 3 clinical trial.
Four hundred twelve patients with Demodex blepharitis were assigned randomly in a 1:1 ratio to receive either lotilaner ophthalmic solution 0.25% (study group) or vehicle without lotilaner (control group).
Patients with Demodex blepharitis treated at 21 United States clinical sites were assigned either to the study group (n = 203) to receive lotilaner ophthalmic solution 0.25% or to the control group (n = 209) to receive vehicle without lotilaner bilaterally twice daily for 6 weeks. Collarettes and erythema were graded for each eyelid at screening and at all visits after baseline. At screening and on days 15, 22, and 43, 4 or more eyelashes were epilated from each eye, and the number of Demodex mites present on the lashes was counted with a microscope. Mite density was calculated as the number of mites per lash.
Outcome measures included collarette cure (collarette grade 0), clinically meaningful collarette reduction to 10 collarettes or fewer (grade 0 or 1), mite eradication (0 mites/lash), erythema cure (grade 0), composite cure (grade 0 for collarettes as well as erythema), compliance with the drop regimen, drop comfort, and adverse events.
At day 43, the study group achieved a statistically significant (P < 0.0001) higher proportion of patients with collarette cure (56.0% vs. 12.5%), clinically meaningful collarette reduction to 10 collarettes or fewer (89.1% vs. 33.0%), mite eradication (51.8% vs. 14.6%), erythema cure (31.1% vs. 9.0%), and composite cure (19.2% vs. 4.0%) than the control group. High compliance with the drop regimen (mean ± standard deviation, 98.7 ± 5.3%) in the study group was observed, and 90.7% of patients found the drops to be neutral to very comfortable.
Twice-daily treatment with lotilaner ophthalmic solution 0.25% for 6 weeks generally was safe and well tolerated and met the primary end point and all secondary end points for the treatment of Demodex blepharitis compared with vehicle control.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Prospective, randomized, double-masked, vehicle-controlled, multicenter, phase 3 clinical trial.
Four hundred twelve patients with Demodex blepharitis were assigned randomly in a 1:1 ratio to receive either lotilaner ophthalmic solution 0.25% (study group) or vehicle without lotilaner (control group).
Patients with Demodex blepharitis treated at 21 United States clinical sites were assigned either to the study group (n = 203) to receive lotilaner ophthalmic solution 0.25% or to the control group (n = 209) to receive vehicle without lotilaner bilaterally twice daily for 6 weeks. Collarettes and erythema were graded for each eyelid at screening and at all visits after baseline. At screening and on days 15, 22, and 43, 4 or more eyelashes were epilated from each eye, and the number of Demodex mites present on the lashes was counted with a microscope. Mite density was calculated as the number of mites per lash.
Outcome measures included collarette cure (collarette grade 0), clinically meaningful collarette reduction to 10 collarettes or fewer (grade 0 or 1), mite eradication (0 mites/lash), erythema cure (grade 0), composite cure (grade 0 for collarettes as well as erythema), compliance with the drop regimen, drop comfort, and adverse events.
At day 43, the study group achieved a statistically significant (P < 0.0001) higher proportion of patients with collarette cure (56.0% vs. 12.5%), clinically meaningful collarette reduction to 10 collarettes or fewer (89.1% vs. 33.0%), mite eradication (51.8% vs. 14.6%), erythema cure (31.1% vs. 9.0%), and composite cure (19.2% vs. 4.0%) than the control group. High compliance with the drop regimen (mean ± standard deviation, 98.7 ± 5.3%) in the study group was observed, and 90.7% of patients found the drops to be neutral to very comfortable.
Twice-daily treatment with lotilaner ophthalmic solution 0.25% for 6 weeks generally was safe and well tolerated and met the primary end point and all secondary end points for the treatment of Demodex blepharitis compared with vehicle control.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
摘要：
目的：评价洛替兰尔眼用溶液的安全性和有效性，与用于治疗蠕形螨眼睑炎的载体相比为0.25%。
方法：前瞻性，随机化，双面蒙面,车辆控制,多中心，3期临床试验。
方法：参与者，和/或对照：以1：1的比例随机分配了四百十二名（412）蠕形眼炎患者，以接受lotilaner眼用溶液，0.25％（研究组）或不含lotilaner的载体（对照组）。
方法：在本研究中，在美国21个临床地点进行，分配到研究组（N=203）的蠕形螨眼睑炎患者接受了lotilaner眼用溶液，0.25%和对照组(N=209)双侧接受无lotilaner的车辆，每天两次，持续六周。在第8、15、22和43天评估患者。在筛选和所有基线后访视时，对每个眼睑的结皮和红斑进行分级。在筛选时，在第15天，第22天和第43天，每只眼睛都有4个或更多的睫毛，用显微镜计数睫毛上存在的蠕形螨的数量。螨密度计算为每个睫毛的螨数量。
方法：结果措施包括配股固化（配股0级），临床上有意义的发条减少至≤10发条(0级或1级)，消除螨（0螨/睫毛），红斑治愈（0级），复合固化（对于卷边和红斑为0级），遵守滴剂方案，跌落舒适度,和不良事件。
结果：在第43天，研究组获得了更高的有统计学意义（p<0.0001）的患者比例（56.0％vs12.5％），临床上有意义的衣领减少至≤10根衣领（89.1%vs33.0%），螨根除(51.8%vs14.6%)，红斑治愈（31.1%vs9.0%），和复合固化（19.2%vs4.0%）比对照组。观察到研究组对下降方案的高依从性（平均值±标准偏差：98.7±5.3％），90.7%的患者发现滴剂是中性的，非常舒适。
结论：每天两次使用lotilaner眼用溶液治疗，与媒介物对照相比,6周的0.25%通常是安全且耐受性良好的,并且达到了用于蠕形螨眼睑炎治疗的主要终点和所有次要终点。
方法：前瞻性，随机化，双面蒙面,车辆控制,多中心，3期临床试验。
方法：参与者，和/或对照：以1：1的比例随机分配了四百十二名（412）蠕形眼炎患者，以接受lotilaner眼用溶液，0.25％（研究组）或不含lotilaner的载体（对照组）。
方法：在本研究中，在美国21个临床地点进行，分配到研究组（N=203）的蠕形螨眼睑炎患者接受了lotilaner眼用溶液，0.25%和对照组(N=209)双侧接受无lotilaner的车辆，每天两次，持续六周。在第8、15、22和43天评估患者。在筛选和所有基线后访视时，对每个眼睑的结皮和红斑进行分级。在筛选时，在第15天，第22天和第43天，每只眼睛都有4个或更多的睫毛，用显微镜计数睫毛上存在的蠕形螨的数量。螨密度计算为每个睫毛的螨数量。
方法：结果措施包括配股固化（配股0级），临床上有意义的发条减少至≤10发条(0级或1级)，消除螨（0螨/睫毛），红斑治愈（0级），复合固化（对于卷边和红斑为0级），遵守滴剂方案，跌落舒适度,和不良事件。
结果：在第43天，研究组获得了更高的有统计学意义（p<0.0001）的患者比例（56.0％vs12.5％），临床上有意义的衣领减少至≤10根衣领（89.1%vs33.0%），螨根除(51.8%vs14.6%)，红斑治愈（31.1%vs9.0%），和复合固化（19.2%vs4.0%）比对照组。观察到研究组对下降方案的高依从性（平均值±标准偏差：98.7±5.3％），90.7%的患者发现滴剂是中性的，非常舒适。
结论：每天两次使用lotilaner眼用溶液治疗，与媒介物对照相比,6周的0.25%通常是安全且耐受性良好的,并且达到了用于蠕形螨眼睑炎治疗的主要终点和所有次要终点。
