一项多中心、双盲、平行分组、安慰剂对照的临床研究，旨在评估 T-Clair SPHP700-3 治疗成人轻至中度干眼的安全性和有效性。
A multicenter, double-blind, parallel group, placebo-controlled clinical study to examine the safety and efficacy of T-Clair SPHP700-3 in the management of mild to moderate dry eye in adults.
机构信息
UO Oculistica, Dipartimento di Neuroscienze e Organi di Senso, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Universitá degli Studi di Milano, Milan, Italy.
出版信息
Cornea. 2011 Mar;30(3):265-8. doi: 10.1097/ICO.0b013e3181e9aab8.
PURPOSE
To study the safety and efficacy of T-Clair SPHP700-3, a new over-the-counter preservative-free formulation, in the management of mild to moderate dry eye in adults.
METHODS
Sixty adult patients with mild to moderate dry eye were consecutively recruited in 2 eye clinics and randomized into 2 groups: treatment and placebo. Signs and symptoms of dry eye were compared along 28 days of treatment.
RESULTS
No adverse events were reported during the study. Symptoms and signs of dry eye showed significant differences between the 2 groups after 2 and 4 weeks of treatment.
CONCLUSIONS
SPHP700-3 preservative-free formulation showed to be safe and effective in mild to moderate dry eye, improving tear film stability, ocular surface lubrification, and patients' symptomatology.
目的
研究 T-Clair SPHP700-3 的安全性和有效性，这是一种新的非处方、无防腐剂配方，用于治疗成人轻至中度干眼症。
方法
在 2 家眼科诊所连续招募了 60 名患有轻至中度干眼症的成年患者，并将他们随机分为 2 组：治疗组和安慰剂组。在 28 天的治疗期间比较了干眼的体征和症状。
结果
研究过程中未报告任何不良事件。治疗 2 周和 4 周后，两组的干眼体征和症状均显示出显著差异。
结论
SPHP700-3 无防腐剂配方对轻至中度干眼症安全有效，可改善泪膜稳定性、眼表面润滑和患者症状。
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