CIBA Vision Corporation, Duluth, GA, USA.
Eye Contact Lens. 2010 Jul;36(4):215-9. doi: 10.1097/ICL.0b013e3181e5859f.
The primary objective of this trial was to explore the extent to which common contact lens-related symptoms may be improved among symptomatic daily wear contact lens wearers who habitually replaced their lenses at intervals of 1 to 4 weeks when fitted with DAILIES AquaComfort Plus for daily disposable, daily wear. Primary variables were frequency and severity of tired eyes, irritated eyes, lens awareness, blurred vision, redness, discomfort, deposits, and dryness.
Eight sites, investigators enrolled 83 subjects who reported two or more of the symptoms with frequency of often or always. A sample size estimate required 60 subjects for 80% power, two-sided alpha = 0.05. Subjects were dispensed for 4 weeks of bilateral lens wear. Follow-up visits were at 2 and 4 weeks; data were collected by telephone surveys at 1 and 3 weeks.
Eighty-one subjects completed the trial. Statistically significant improvements in symptom frequency were found for the symptoms of tired eyes (P<0.001), irritated eyes (P<0.001), blurred vision (P<0.001), redness (P<0.001), discomfort (P=0.024), deposits/lens needs cleaning (P<0.001), and dryness (P<0.001). Statistically significant improvements in symptom severity were found for tired eyes (P<0.001), irritated eyes (P<0.001), blurred vision (P<0.001), redness (P<0.001), discomfort (P=0.037), deposits/lens needs cleaning (P<0.001), and dryness (P<0.001). Biomicroscopy signs of limbal redness, bulbar redness, and conjunctival staining showed statistically significant improvements at 2 weeks (P=0.02, 0.01, and 0.035) and 4 weeks (P< or =0.001, 0.012, and 0.008).
A range of common symptoms can be reduced and biomicroscopy signs can be improved with a comfort-enhanced daily disposable, daily wear lens, thus providing benefits that patients can experience and eye care practitioners can appreciate.
本试验的主要目的是探究频繁更换镜片的日戴型频繁接触镜佩戴者在使用 DAILIES AquaComfort Plus 日戴型一次性镜片时,常戴型接触镜相关症状的改善程度。主要变量是眼疲劳、眼刺激、镜片感知、视力模糊、眼红、不适、沉淀物和眼干的频率和严重程度。
在 8 个试验点,83 名经常或总是出现 2 种或以上症状的研究对象参与了该项研究。根据 80%的功效和双侧α=0.05,需要 60 名研究对象。研究对象接受了 4 周的双侧镜片佩戴。随访时间为第 2 周和第 4 周;第 1 周和第 3 周通过电话调查收集数据。
81 名研究对象完成了试验。眼疲劳(P<0.001)、眼刺激(P<0.001)、视力模糊(P<0.001)、眼红(P<0.001)、不适(P=0.024)、沉淀物/镜片需要清洁(P<0.001)和眼干(P<0.001)等症状的出现频率均有统计学显著改善。眼疲劳(P<0.001)、眼刺激(P<0.001)、视力模糊(P<0.001)、眼红(P<0.001)、不适(P=0.037)、沉淀物/镜片需要清洁(P<0.001)和眼干(P<0.001)等症状的严重程度也有统计学显著改善。第 2 周和第 4 周时,角膜缘红、球结膜红和结膜染色的临床生物显微镜征象均有统计学显著改善(P=0.02、0.01 和 0.035;P<或=0.001、0.012 和 0.008)。
使用舒适度增强型日戴型一次性镜片可减少多种常见症状,并改善临床生物显微镜征象,使患者能体验到益处,眼保健从业者也能欣赏到益处。