Stiegemeier Mary Jo, Cedrone Ronald, Evans David, Friederichs Greg, Holle Douglas, Jenkins William, Lutzi Dagmar, Roberson Rex, Schenker Howard, White Eric, Zigler Lamar
Cont Lens Anterior Eye. 2004 Jun;27(2):65-74. doi: 10.1016/j.clae.2004.02.003.
This was a multi-site, 231-subject double-masked, bilateral crossover study to evaluate subjective comfort and satisfaction, corneal staining and lens deposits with two 'no rub' multi-purpose solutions (MPS) used with FDA Group II (alphafilcon A, SofLens 66, Bausch & Lomb) and Group IV (etafilcon A, SUREVUE, Johnson & Johnson Vision Care) soft contact lenses. Subjects used each of the two MPS, Regimen 1 (OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution No Rub Lasting Comfort Formula, Alcon Laboratories) and Regimen 2 (ReNu MultiPlus Multi-Purpose Solution, Bausch & Lomb), for 28 days. They wore the same lens type for the duration of the study and were evaluated on days 0, 14 and 28 of each treatment period. Subjective ratings of comfort and satisfaction were significantly different between regimens, with the majority of variables in favour of Regimen 1 (P < 0.05). Corneal staining was significantly greater with the Group II, Regimen 2 combination (P < 0.0001). Group IV lenses cared for with Regimen 1 had significantly less residual lysozyme on Day 28 (562 microg) than lenses cared for with Regimen 2 (1145 microg; P < 0.0001). While both products offer the convenience of a 'no rub' regimen, differences in performance should be considered when recommending these solutions to patients.
这是一项多中心、涉及231名受试者的双盲双侧交叉研究，旨在评估使用两种“免揉搓”多功能护理液（MPS）护理FDA II类（阿尔法氟康A，SofLens 66，博士伦）和IV类（依他氟康A，SUREVUE，强生视力健）软性隐形眼镜时的主观舒适度和满意度、角膜染色情况以及镜片沉积物。受试者分别使用两种MPS，方案1（爱尔康实验室的傲滴恒润免揉搓多功能护理液）和方案2（博士伦的乐敦清全护理液），各使用28天。在研究期间，他们佩戴相同类型的镜片，并在每个治疗周期的第0天、第14天和第28天进行评估。方案之间的舒适度和满意度主观评分存在显著差异，大多数变量显示方案1更优（P < 0.05）。使用方案2护理II类镜片时，角膜染色明显更严重（P < 0.0001）。在第28天，用方案1护理的IV类镜片残留溶菌酶（562微克）明显少于用方案2护理的镜片（1145微克；P < 0.0001）。虽然两种产品都提供了“免揉搓”方案的便利性，但在向患者推荐这些护理液时，应考虑其性能差异。
