Stiegemeier Mary Jo, Friederichs Greg J, Hughes Jane Lindell, Larsen Steven, Movic Wilson, Potter William B
3690 Orange Place, Suite 150, Beachwood, OH 44122, USA.
Cont Lens Anterior Eye. 2006 Jul;29(3):143-51. doi: 10.1016/j.clae.2006.03.006. Epub 2006 May 12.
To evaluate the safety and efficacy of a new multi-purpose disinfecting solution (MPDS) in symptomatic soft contact lens wearers using Group IV soft lenses and compare its performance with that of a marketed MPS.
This was a 4-week, randomized, concurrently controlled, double-masked, multi-site study involving 362 subjects at 19 investigational sites in the US. Existing Group IV lens wearers, pre-screened to be symptomatic for contact lens-related ocular discomfort, were fitted with a new pair of lenses that matched their pre-study lens brand then randomly assigned to one of two treatment regimens: Regimen 1 (OPTI-FREE RepleniSH MPDS, Alcon Laboratories Inc.) or Regimen 2 (ReNu MultiPlus MPS No Rub Formula, Bausch and Lomb Inc.). At Day 0 (baseline), Days 14 and 28 subjects recorded comfort and ocular symptoms, wearing time, rewetting drop and lens removal frequency, and investigators assessed slit-lamp findings, lens deposits and wettability, and visual acuity.
Total corneal staining mean score was significantly lower for the Regimen 1 group at Day 14 (P<or=0.02). Comfort and dryness mean scores were significantly better for Regimen 1 compared to Regimen 2 at Day 28 (P<or=0.02; P<or=0.007) and mean scores for scratchiness and burning were significantly lower at Day 14 (P<or=0.04; P<or=0.01). Significant differences were noted in favor of Regimen 1 on 12 of the 12 Likert questionnaire statements (P<0.05). Average lens wearing time was significantly greater for the Regimen 1 group compared to the Regimen 2 group at Day 14 (P<0.05). Lens deposits were significantly lower with Regimen 1 than with Regimen 2 (P<or=0.02).
This study shows that the new formulation is safe and efficacious when used by symptomatic Group IV lens wearers. Comfort, ocular signs and symptoms and wearing times in patients experiencing problems with their contact lenses can be influenced by the choice of MPS. Selecting an appropriate lens care product enhances patients' wearing experience, maintains optimal lens performance and may help to prevent drop-out.
评估一种新型多用途消毒溶液（MPDS）对使用IV类软性隐形眼镜且有症状的佩戴者的安全性和有效性，并将其性能与市售的多用途溶液（MPS）进行比较。
这是一项为期4周的随机、同期对照、双盲、多中心研究，在美国19个研究地点纳入了362名受试者。预先筛选出有与隐形眼镜相关眼部不适症状的现有IV类镜片佩戴者，为其配戴一副与研究前镜片品牌匹配的新镜片，然后随机分配至两种治疗方案之一：方案1（爱尔康实验室公司的OPTI-FREE RepleniSH MPDS）或方案2（博士伦公司的ReNu MultiPlus MPS免揉搓配方）。在第0天（基线）、第14天和第28天，受试者记录舒适度和眼部症状、佩戴时间、润眼液使用情况和摘镜频率，研究人员评估裂隙灯检查结果、镜片沉积物和润湿性以及视力。
在第14天，方案1组的角膜总染色平均得分显著更低（P≤0.02）。在第28天，方案1组的舒适度和干燥度平均得分显著优于方案2组（P≤0.02；P≤0.007），在第14天，瘙痒和灼烧的平均得分显著更低（P≤0.04；P≤0.01）。在12项李克特问卷陈述中有12项显示方案1具有显著优势（P<0.05）。在第14天，方案1组的平均镜片佩戴时间显著长于方案2组（P<0.05）。方案1组的镜片沉积物显著低于方案2组（P≤0.02）。
本研究表明，这种新配方对于有症状的IV类镜片佩戴者来说安全有效。隐形眼镜出现问题的患者的舒适度、眼部体征和症状以及佩戴时间会受到多用途溶液选择的影响。选择合适的镜片护理产品可提升患者的佩戴体验，维持镜片的最佳性能，并可能有助于防止患者放弃佩戴。
