Asociación para Evitar la Ceguera en México I.A.P., Mexico City, Mexico.
Kentucky Eye Institute, Lexington, KY, USA.
Cont Lens Anterior Eye. 2022 Aug;45(4):101492. doi: 10.1016/j.clae.2021.101492. Epub 2021 Jul 28.
To evaluate the safety and efficacy of lotilaner ophthalmic solution, 0.25% for the treatment of blepharitis due to Demodex infestation compared to vehicle control.
In this phase II, randomized, controlled, double-masked clinical trial, 60 eligible participants with Demodex blepharitis were randomly assigned in a 1:1 ratio to receive either topical lotilaner ophthalmic solution, 0.25% (Tarsus Pharmaceuticals, Inc., Irvine, CA) (study group) or the vehicle without lotilaner (control group) bilaterally twice a day for 28 days. Participants were followed at Days 7, 14, 28, 60 and 90. The efficacy parameters were change in collarette grade and Demodex density at Day 28. Safety parameters were adverse events, changes in corrected distance visual acuity (CDVA), intraocular pressure (IOP) and slit-lamp biomicroscopy.
The study group showed a statistically significant decrease in collarette grade compared to the control group beginning at Day 14 (p = 0.003) in the upper eyelid and at Day 28 (p = 0.003) in the lower eyelid. Decreases in both lids were maintained through Day 90 (p < 0.001). At Day 28, mite eradication was achieved in 66.7% and 25.9% of eyes in the study and control group (p = 0.005); at Day 90, these proportions were 68.2% and 18.5% (p = 0.001), respectively. No serious adverse events or clinically significant changes in CDVA and IOP were observed.
For Demodex blepharitis, treatment with lotilaner ophthalmic solution, 0.25% for 4 weeks is safe and effective. The improvement in collarette grade and mite density observed during the treatment period persisted for at least two months following treatment cessation.
评估 0.25%洛替拉纳滴眼液治疗蠕形螨感染性睑缘炎的安全性和有效性，与赋形剂对照。
在这项 2 期、随机、对照、双盲临床试验中，将 60 例符合蠕形螨性睑缘炎条件的合格参与者按照 1:1 的比例随机分配，接受每日 2 次、双侧滴用 0.25%洛替拉纳滴眼液（Tarsus Pharmaceuticals，Irvine，CA）（研究组）或不含洛替拉纳的赋形剂（对照组）治疗，疗程为 28 天。参与者在第 7、14、28、60 和 90 天随访。疗效参数为第 28 天的睫毛根部等级和蠕形螨密度变化。安全性参数为不良事件、矫正视力（CDVA）、眼压（IOP）和裂隙灯生物显微镜的变化。
与对照组相比，研究组从第 14 天（上睑，p=0.003）和第 28 天（下睑，p=0.003）开始，睫毛根部等级呈统计学显著下降，并在第 90 天持续下降（p<0.001）。在第 28 天，研究组和对照组的 66.7%和 25.9%的眼实现了螨虫清除（p=0.005）；在第 90 天，这些比例分别为 68.2%和 18.5%（p=0.001）。未观察到严重不良事件或 CDVA 和 IOP 的临床显著变化。
对于蠕形螨性睑缘炎，使用 0.25%洛替拉纳滴眼液治疗 4 周是安全有效的。在治疗期间观察到的睫毛根部等级和螨虫密度的改善在治疗停止后至少两个月内持续存在。
