University of Applied Sciences (FHNW), Institute of Optometry, Olten, Switzerland.
University of Applied Sciences (FHNW), Institute of Optometry, Olten, Switzerland.
Cont Lens Anterior Eye. 2021 Jun;44(3):101318. doi: 10.1016/j.clae.2020.04.003. Epub 2020 Apr 27.
To subjectively and objectively evaluate the efficacy and tolerability of preservative-free Ectoin ® Eye Spray - Colloidal (EES09) and Tears Again ® Eye Spray (TA) in subjects with mild-moderate dry eye disease (DED), and to compare efficacy of these two eye sprays with each other.
Thirty-six volunteers (average age 32.3 ± 16.1 years; 26 females) were successfully recruited for this prospective double-blind study with between-subject design and randomly divided into two groups (gender and age balanced): Group A received EES09 and Group B received TA during the treatment phase. Inclusioncriteria were a minimum age of 18 years, a score of 18.0 or higher on the OSDI questionnaire, and a non-invasive tear break up time (NIKBUT, Oculus Keratograph M5, Oculus, Germany) of no more than 10s in at least one eye. The objective variables NIKBUT, conjunctival redness, lipid layer and osmolarity (TearLab Cooperation, USA) were assessed at baseline, 10 min. after spray application and after a treatment phase of 10±3 days (3x applications daily). Symptoms, tolerance and handling were evaluated with the OSDI and VAS questionnaires.
A statistically significant increase in NIKBUT and improvement in DED symptoms were obtained for the overall group (mean NIKBUT 7.7 ± 1.7s vs. 11.6 ± 4.6s, p<0.001; mean OSDI score: 36.1 ± 12.7 vs. 20. 7± 12.7, p<0.001) during course of treatment. No statistically significant effect was established for the variables lipid layer (p = 0.406), conjunctival redness (p = 0.766) and osmolarity (p = 0.378). No statistically significant differences were observed between the groups, for any variable. The noninferioritycriterion for EES09 towards TA could be shown for the scores of the dry eye symptoms via VAS questionnaire and the variable NIKBUT.
A beneficial treatment effect was confirmed for both, symptoms of DED and the objective variable NIKBUT. Both eye sprays were rated favourably in view of perceived tolerability and handling of the spray bottle.
主观和客观评估无防腐剂依克多因滴眼液 - 胶体（EES09）和 Tears Again ® 滴眼液（TA）在轻度至中度干眼症（DED）患者中的疗效和耐受性，并比较这两种滴眼液的疗效。
36 名志愿者（平均年龄 32.3 ± 16.1 岁；26 名女性）成功入组，进行前瞻性双盲研究，采用组间设计，并随机分为两组（性别和年龄均衡）：A 组接受 EES09，B 组接受 TA 治疗。纳入标准为年龄至少 18 岁，OSDI 问卷评分≥18.0，至少一只眼非侵入性泪膜破裂时间（NIKBUT，Oculus Keratograph M5，Oculus，德国）不超过 10s。在基线、喷雾后 10 分钟和 10±3 天（每天 3 次）的治疗阶段评估客观变量 NIKBUT、结膜充血、脂质层和渗透压（TearLab 合作，美国）。使用 OSDI 和 VAS 问卷评估症状、耐受性和处理。
总体组在 NIKBUT 和改善 DED 症状方面均获得统计学显著增加（平均 NIKBUT 7.7 ± 1.7s 与 11.6 ± 4.6s，p<0.001；平均 OSDI 评分：36.1 ± 12.7 与 20.7±12.7，p<0.001）。治疗过程中，脂质层（p = 0.406）、结膜充血（p = 0.766）和渗透压（p = 0.378）等变量无统计学显著影响。组间各变量均无统计学差异。EES09 对 TA 的非劣效性可通过 VAS 问卷和 NIKBUT 变量的干眼症症状评分得到证实。
两种滴眼液均证实对 DED 症状和客观变量 NIKBUT 具有有益的治疗效果。两种滴眼液在可接受性和喷雾瓶处理方面均得到了好评。
