ABSTRACT

Purpose/Aim of the study

To evaluate the improvement of ocular signs and symptoms in patients suffering from Demodex blepharitis using a combined treatment approach: use of eyelid wipes impregnated with 2.5% terpinen-4-ol (T4O) and 0.2% hyaluronic acid (HA) in the initial treatment period and investigation of maintenance of the treatment effect with the use of eyelid cleansing wipes.

Materials and Methods

Fifty patients with Demodex blepharitis were treated in the initial treatment period with sterile eyelid T4O impregnated wipes for 28 days. In the following four-week maintenance period, 82% patients received sterile eyelid maintenance wipes, while 16% continued treatment with T4O impregnated wipes. Global ocular discomfort, adapted TOSS, SANDE score, and individual blepharitis symptoms were assessed by patients at day 28 and day 56. Ocular signs were evaluated by the investigator at the study visits. Investigator’s assessment of the overall treatment performance, patient’s assessment of treatment satisfaction, and tolerability were evaluated with questionnaires.

Results

All global ocular discomfort symptoms and disease specific symptoms assessed by patients as well as all parameters evaluated by the investigators significantly improved in the initial treatment period with the application of eyelid wipes impregnated with 2.5% terpinen-4-ol until day 28. The therapeutic effect was maintained or even improved during the maintenance period under administration of mainly eyelid maintenance wipes until day 56. Both products were well tolerated. No adverse events and no clinically relevant changes in visual acuity were observed during both periods.

Conclusions

Once daily treatment with T4O impregnated eyelid wipes in the initial treatment period significantly improved the ocular symptoms and signs and reduced the mite count in patients with Demodex blepharitis within four-weeks administration. Subsequent maintenance treatment with maintenance wipes for another 4 weeks preserved or further intensified the treatment success. The products were well tolerated and were convenient to use.

中文翻译：

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管理蠕形螨睑缘炎的不同方法 - 初始和维持治疗

摘要

研究目的/目的

使用联合治疗方法评估蠕形螨患者眼部症状和体征的改善情况：在初始治疗期间使用浸渍有 2.5% 萜品烯-4-醇 (T4O) 和 0.2% 透明质酸 (HA) 的眼睑湿巾并调查使用眼睑清洁湿巾维持治疗效果。

材料和方法

50 名蠕形螨睑缘炎患者在初始治疗期间用无菌眼睑 T4O 浸渍湿巾治疗 28 天。在接下来的 4 周维持期中，82% 的患者接受了无菌眼睑维持湿巾，而 16% 的患者继续使用 T4O 浸渍湿巾进行治疗。患者在第 28 天和第 56 天评估了整体眼部不适、适应的 TOSS、SANDE 评分和个体睑缘炎症状。研究人员在研究访问时评估了眼部体征。研究者对整体治疗表现的评估、患者对治疗满意度的评估和耐受性通过问卷进行评估。

结果

患者评估的所有整体眼部不适症状和疾病特异性症状以及研究人员评估的所有参数在初始治疗期间使用浸渍有 2.5% 萜品烯-4-醇的眼睑湿巾直至第 28 天均显着改善。治疗效果在主要使用眼睑保养湿巾直至第 56 天的情况下，在维持期间维持甚至改善。这两种产品都具有良好的耐受性。两个时期均未观察到不良事件和临床相关的视力变化。

结论

在初始治疗期间，每天一次用浸渍 T4O 的眼睑湿巾治疗，在给药 4 周内显着改善了蠕形螨睑缘炎患者的眼部症状和体征，并减少了螨虫数量。随后用维持湿巾再进行 4 周的维持治疗保留或进一步加强了治疗的成功率。产品耐受性好，使用方便。