Lyu Yee-Ran, Kwon O-Jin, Park Bongkyun, Jung Hyun-A, Lee Ga-Young, Kim Chan-Sik
Korean Medicine Science Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea.
Korean Medicine Convergence Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea.
Healthcare (Basel). 2024 Nov 27;12(23):2383. doi: 10.3390/healthcare12232383.
Dry eye disease (DED) is a very frequently encountered ocular disease, making it a growing public health burden. However, current treatments for DED present unmet medical needs owing to their side effects or ineffectiveness. Therefore, an effective and safe therapeutic agent to manage DED is needed. We planned a phase 2, dose-finding, double-blind, randomized placebo-controlled trial to evaluate the efficacy and safety of two different doses of USL (Useul), the extract of Achyranthis Radix, compared with placebo, for DED. USL has been found to protect against DED by inducing tear secretion and improving corneal irregularity via anti-inflammatory effects, which will provide new therapeutic options. One hundred and twenty participants will be enrolled, after assessing the inclusion/exclusion criteria, at Daejeon University Daejeon Korean Medicine Hospital. Enrolled participants will be allocated to standard-dose USL, high-dose USL, or placebo groups in a 1:1:1 ratio and will be required to administer the trial medication twice a day for 12 weeks and visit the clinic five times. For efficacy outcomes, objective endpoints of fluorescein corneal staining score, tear break-up time, Schirmer's test, and meibomian test and subjective endpoints of Ocular Surface Disease Index, visual analog scale, Standard Patient Evaluation for Eye Dryness-II, and biomarkers will be assessed throughout the trial. Safety will be assessed based on adverse events, vital signs, laboratory tests, visual acuity, and intraocular pressure. Our study results are expected to provide clinical evidence for the use of DED as an effective and safe agent for DED.
干眼症（DED）是一种非常常见的眼部疾病，使其成为日益沉重的公共卫生负担。然而，目前针对干眼症的治疗方法由于其副作用或无效性而存在未满足的医疗需求。因此，需要一种有效且安全的治疗药物来治疗干眼症。我们计划进行一项2期、剂量探索、双盲、随机安慰剂对照试验，以评估两种不同剂量的牛膝提取物（Useul，USL）与安慰剂相比治疗干眼症的疗效和安全性。已发现USL可通过诱导泪液分泌和通过抗炎作用改善角膜不规则性来预防干眼症，这将提供新的治疗选择。在评估纳入/排除标准后，将在大田大学大田韩医医院招募120名参与者。入选的参与者将按1:1:1的比例分配到标准剂量USL组、高剂量USL组或安慰剂组，并被要求每天服用试验药物两次，持续12周，并到诊所就诊五次。对于疗效结果，在整个试验过程中，将评估荧光素角膜染色评分、泪膜破裂时间、泪液分泌试验、睑板腺功能检查等客观终点指标，以及眼表疾病指数、视觉模拟评分、干眼标准患者评估-II和生物标志物等主观终点指标。将根据不良事件、生命体征、实验室检查、视力和眼压评估安全性。我们的研究结果有望为USL作为一种有效且安全的干眼症治疗药物的使用提供临床证据。
