Two different concentrations of Opti-Plus® compared for daily protein cleaning of a disposable contact lens

Russell Lowe, M.-L.Chantal Coles, Noel A Brennan
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引用次数: 1

Abstract

The aim of this study was to compare the relative safety, efficacy, comfort, and convenience of the daily use of a pancreatin-based, liquid enzyme daily protein remover (DPR) at two different concentrations for protein cleaning of Group IV disposable contact lenses.

We enrolled 73 subjects (146 eyes) into a 3-month, randomized, investigator-masked clinical study comparing a test regimen of DPR (Opti-Plus® or Supra-Clens®) containing four drops per 10 mL of multifunctional solution (Opti-Free®) to a control regimen containing only two drops per 10 mL of multifunctional solution.

The liquid enzyme regimens provided safe and effective protein cleaning of the Group IV lenses with no additional cleaning benefit observed at the higher concentration. Three convenience parameters (steps required, time required, and dexterity required) had mean improvements for both regimens at Day 90 compared to baseline (Day 0). Thus, subjects perceived the DPR regimen as more convenient than their pre-study regimen, which required weekly use of an enzymatic cleaning tablet. Comfort remained consistent with baseline levels throughout the study regardless of concentration of DPR for 72 of 73 subjects.

This study provided evidence that the daily use of a low concentration pancreatin enzymatic solution admixed with multifunctional solution is well tolerated and provides a more convenient method of achieving simultaneous disinfection and protein cleaning during contact lens storage than enzyme tablets.

两种不同浓度的Opti-Plus®用于一次性隐形眼镜的日常蛋白质清洁的比较
本研究的目的是比较日常使用两种不同浓度的胰酶液体酶每日蛋白去除剂(DPR)清洁第IV组一次性隐形眼镜的相对安全性、有效性、舒适性和便利性。我们招募了73名受试者(146只眼睛)参加了一项为期3个月的随机临床研究,比较了每10毫升多功能溶液(Opti-Free®)含有4滴DPR (Opti-Plus®或supera - clens®)的测试方案和每10毫升多功能溶液仅含有2滴的对照方案。液体酶方案为IV组镜片提供了安全有效的蛋白质清洁,在更高浓度下没有观察到额外的清洁效果。三个便利参数(所需步骤、所需时间和所需灵活性)在第90天与基线(第0天)相比,两种方案的平均改善。因此,受试者认为DPR方案比他们的研究前方案更方便,研究前方案需要每周使用酶清洗片。在整个研究过程中,无论DPR浓度如何,73名受试者中有72名的舒适度与基线水平保持一致。本研究提供了证据,证明日常使用低浓度胰酶溶液与多功能溶液混合使用具有良好的耐受性,并且提供了一种比酶片更方便的方法来实现隐形眼镜储存期间同时消毒和蛋白质清洁。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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