一种用于缓解眼部干涩的含羟丙基瓜尔胶可凝胶化润滑眼药水的临床评估。
Clinical evaluation of an HP-guar gellable lubricant eye drop for the relief of dryness of the eye.
作者信息
Christensen Mike T, Cohen Steven, Rinehart John, Akers Frank, Pemberton Bart, Bloomenstein Marc, Lesher Mark, Kaplan David, Meadows David, Meuse Patricia, Hearn Charles, Stein Jerry M
机构信息
Alcon Labs, Consumer Products, Fort Worth, TX, USA.
出版信息
Curr Eye Res. 2004 Jan;28(1):55-62. doi: 10.1076/ceyr.28.1.55.23495.
PURPOSE
To evaluate the efficacy of a new lubricant eye drop containing polyethylene glycol 400 and propylene glycol demulcents with hydroxypropyl-guar as a gelling agent (Test Product) to a system with carboxymethylcellulose (Control Product) for reducing dry eye signs and symptoms.
METHODS
Eighty-seven dry eye volunteers were enrolled at seven sites for this six-week, concurrently controlled, double-masked clinical study.
RESULTS
The Test Product significantly reduced conjunctival staining (p = 0.025) and temporal corneal staining (p = 0.024) compared to the Control. The Test Product also significantly reduced symptoms of dryness in the morning and evening, compared to the Control (p = 0.015 and p = 0.023, respectively). Subjects in the Test treatment group reported lower frequencies of foreign body sensation and felt their eyes were "refreshed longer" compared to those in the Control group (p = 0.033 and p = 0.037, respectively).
CONCLUSIONS
The Test Product was more effective at reducing both the signs and symptoms of dry eye compared to the carboxymethylcellulose containing Control.
目的
评估一种含有聚乙二醇400和丙二醇润肤剂并以羟丙基瓜尔胶作为胶凝剂的新型润滑眼药水（测试产品）与含有羧甲基纤维素的对照产品相比，在减轻干眼体征和症状方面的疗效。
方法
八十七名干眼志愿者在七个地点参加了这项为期六周的同期对照双盲临床研究。
结果
与对照产品相比，测试产品显著减少了结膜染色（p = 0.025）和颞侧角膜染色（p = 0.024）。与对照产品相比，测试产品还显著减轻了早晚的干眼症状（分别为p = 0.015和p = 0.023）。与对照组相比，测试治疗组的受试者报告异物感频率更低，并感觉眼睛“清爽的时间更长”（分别为p = 0.033和p = 0.037）。
结论
与含羧甲基纤维素的对照产品相比，测试产品在减轻干眼体征和症状方面更有效。
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