Division of Biology, Food and Drug Administration, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Silver Spring, MD, USA.
Eye Contact Lens. 2012 Nov;38(6):368-73. doi: 10.1097/ICL.0b013e31826f0893.
To determine the effect of 8 different lens materials on polyhexamethylene biguanide (PHMB) concentration in multipurpose solution (MPS) levels over time and to determine the effect of lenses on lens solution microbial efficacy over time.
Silicone hydrogel lenses and conventional hydrogel lenses were soaked in polypropylene lens cases filled with contact lens MPS containing 1 ppm PHMB for 6, 12, 24, 72, and 168 hours. Cases filled with the same solution without lenses were controls. After each time period, solutions from cases with the 8 types of lenses and controls were assayed for activity against Staphylococcus aureus according to International Organization for Standardization-14729 with modifications. Solutions were analyzed for PHMB concentration at each time point.
Some of the different lens materials significantly affected the PHMB concentration (P<0.0001) and the biocidal efficacy. Etafilcon A lenses significantly decreased PHMB levels after only 6 hours of lens soak time. The product lot of MPS used was also significant (P<0.0001). Enfilcon A, senofilcon A, and lotrafilcon B lenses did not significantly decrease PHMB levels.
The efficacy of MPS was affected by some lens materials and PHMB concentration. Lens materials differ in their effect on PHMB concentration and the subsequent efficacy of the MPS. Over time, some lens materials can significantly reduce the PHMB concentration and the MPS's microbial activity against S. aureus.
确定 8 种不同镜片材料对多功能溶液(MPS)中聚六亚甲基双胍(PHMB)浓度随时间的影响,并确定镜片对镜片溶液微生物功效随时间的影响。
将硅水凝胶镜片和传统水凝胶镜片浸泡在充满含有 1ppm PHMB 的隐形眼镜 MPS 的聚丙烯镜片盒中 6、12、24、72 和 168 小时。没有镜片的相同溶液填充的盒子作为对照。在每个时间段后,从装有 8 种类型镜片和对照的盒子中的溶液根据国际标准化组织-14729 进行修改,对抗金黄色葡萄球菌的活性进行测定。在每个时间点分析溶液中的 PHMB 浓度。
一些不同的镜片材料显著影响 PHMB 浓度(P<0.0001)和杀菌功效。仅浸泡 6 小时后,艾氟龙 A 镜片显著降低 PHMB 水平。使用的 MPS 产品批次也很重要(P<0.0001)。依视康 A、新视康 A 和 lotrafilcon B 镜片没有显著降低 PHMB 水平。
MPS 的功效受到一些镜片材料和 PHMB 浓度的影响。镜片材料在其对 PHMB 浓度的影响以及随后 MPS 的功效方面存在差异。随着时间的推移,一些镜片材料会显著降低 PHMB 浓度和 MPS 对金黄色葡萄球菌的微生物活性。