该临床试验是作为医疗装置的营销程序的一部分进行的,该医疗装置包含含有具有二核苷酸的卤虫提取物的人工泪液。这些分子先前通过增强水溶液的产生而证明了促分泌特性,粘液,和眼泪的脂类成分。
■在动物模型中确认含有卤虫提取物的人工泪液的功效后,本研究评估其对干眼参与者的疗效和安全性.
■对36名干眼参与者(41.6±20.6年)进行了一项随机对照临床试验。一半的参与者用盐溶液作为安慰剂治疗四周,另一半用含有卤虫的人工泪液治疗,随机分配。经过两周的清洗期,再交叉治疗4周。参与者在基线和一周后进行评估,两周,还有四个星期.疗效变量为:眼睛干燥频率(主要),眼睛舒适,视觉满意度,泪液分泌,撕碎时间,角膜染色,结膜染色,和结膜充血.安全变量是:高对比度和低对比度视力,眼内压,和眼底图像分析。
■与基线相比,治疗4周后,盐水溶液在任何研究变量中均无显著变化(p≥0.05).然而,用卤虫局部滴注人工泪液4周可显着改善眼睛干燥频率(p=0.014)和角膜染色(p=0.010)。临床试验期间未报告全身或眼部不良事件。
在轻度至中度干眼症参与者中局部滴注含有卤虫的人工泪液四周,轻微改善了他们与眼睛干燥频率相关的症状,并减少了角膜损伤,没有观察到不良副作用。
UNASSIGNED: This clinical trial was conducted as part of the marketing procedures for a medical device comprising artificial tears containing Artemia salina extract with dinucleotides. These molecules previously demonstrated secretagogue properties by enhancing the production of aqueous, mucinous, and lipidic components of the tears.
UNASSIGNED: After confirming the efficacy of artificial tears containing Artemia salina extract in an animal model, this study proceeded to evaluate their efficacy and safety on dry eye participants.
UNASSIGNED: A randomised controlled clinical trial was performed on 36 dry eye participants (41.6 ± 20.6 years). Half of the participants were treated with saline solution as a placebo for four weeks, while the other half were treated with artificial tears containing Artemia salina, randomly assigned. After a wash-out period of two weeks, the treatments were crossed for another four weeks. Participants were assessed at baseline and after one week, two weeks, and four weeks. Efficacy variables were: eye dryness frequency (primary), eye comfort, visual satisfaction, tear secretion, tear break-up time, corneal staining, conjunctival staining, and conjunctival hyperaemia. Safety variables were: high- and low-contrast visual acuity, intraocular pressure, and eye fundus images analysis.
UNASSIGNED: Compared with the baseline, the saline solution showed no significant changes in any of the studied variables after four weeks of treatment (p ≥ 0.05). However, the topical instillation of the artificial tears with Artemia salina for four weeks significantly improved eye dryness frequency (p = 0.014) and corneal staining (p = 0.010). No systemic or ocular adverse events were reported during the clinical trial.
UNASSIGNED: The topical instillation of artificial tears containing Artemia salina in mild to moderate dry eye participants for four weeks slightly improved their symptoms related to eye dryness frequency and reduced corneal damage, with no undesirable side effects observed.