IOBA-Eye Institute and Department of Physics TAO - School of Optometry, University of Valladolid, Valladolid, Spain.
Cont Lens Anterior Eye. 2011 Feb;34(1):17-21. doi: 10.1016/j.clae.2010.09.003. Epub 2010 Oct 25.
To evaluate the safety, physiological performance, and effect on ocular tissues of a new multipurpose disinfecting solution (MPDS) specifically formulated for use with silicone hydrogel (SH) contact lenses (CL).
Two MPDS [solution A (Solo-care Aqua(®), Ciba-Vision) and solution B (Hidro Health(®), Disop)] were randomly assigned and prescribed in a clinical trial in a crossover clinical trial (Registered #293/07/EC; Spanish National Health Department). Only lotrafilcon B CL daily wearers were included. After each solution was used, a masked investigator assessed the slit-lamp findings (SL9, Topcon Inc.), lens deposits, and wettability according to the Guidance for clinical investigation (ISO 11980). CL daily wearing time (hours per day and days per week) were recorded.
Fifty-four daily wearers were included. Average CL wear time was 8.3 ± 2.3 (CI95% 7.9-8.7) hours per day (8.5 ± 2.7 at baseline visit, 8.2 ± 1.9 with solution A, and 8.4 ± 2.2 with solution B). The average number of days per week of CL wear was 5.9 ± 1.3 (CI95% 5.6-6.1) (5.4 ± 1.6 at baseline visit, 6.1 ± 0.9 with solution A, and 6.0 ± 1.1 with solution B). Non-adverse slit-lamp findings were recorded (higher than 2 points). No statistical difference (P>0.05 Friedman test) in CL wearing time, number of days of CL wears and slit-lamp findings were found between the two solutions.
This clinical trial shows that the new formulation of Hidro Health(®) MPDS is safe when used for the care of daily-wear lotrafilcon B CL. This new solution has no clinical significance on ocular tissues, according to the Guidance for clinical investigation (ISO 11980).
评估一种专为硅水凝胶（SH）隐形眼镜（CL）设计的新型多功能消毒溶液（MPDS）的安全性、生理性能和对眼部组织的影响。
在一项交叉临床试验（注册号 293/07/EC；西班牙国家卫生部）中，随机分配和规定使用两种 MPDS[溶液 A（Solo-care Aqua(®)，CIBA-VISION）和溶液 B（Hidro Health(®)，Disop）]。仅包括 lotrafilcon B CL 日戴者。每次使用后，一名掩蔽研究员根据临床调查指南（ISO 11980）评估裂隙灯检查结果（SL9，Topcon Inc.）、镜片沉积物和润湿性。记录 CL 每日佩戴时间（每天小时数和每周天数）。
共纳入 54 名日戴者。平均 CL 佩戴时间为 8.3 ± 2.3（CI95% 7.9-8.7）小时/天（基线访视时为 8.5 ± 2.7，使用溶液 A 时为 8.2 ± 1.9，使用溶液 B 时为 8.4 ± 2.2）。CL 佩戴周数平均为 5.9 ± 1.3（CI95% 5.6-6.1）（基线访视时为 5.4 ± 1.6，使用溶液 A 时为 6.1 ± 0.9，使用溶液 B 时为 6.0 ± 1.1）。记录到非不良的裂隙灯检查结果（高于 2 分）。两种溶液之间 CL 佩戴时间、CL 佩戴天数和裂隙灯检查结果无统计学差异（P>0.05 Friedman 检验）。
这项临床试验表明，当用于日常佩戴的 lotrafilcon B CL 护理时，Hidro Health(®) MPDS 的新配方是安全的。根据临床调查指南（ISO 11980），这种新溶液对眼部组织没有临床意义。
