Clinical performance of a mid-viscosity artificial tear for dry eye treatment
Clinical performance of a mid-viscosity artificial tear for dry eye treatment
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DOI：
10.1097/ico.0b013e31802e1e04
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发表时间：
2007-04-01
期刊：
影响因子：
2.8
通讯作者：
Vehige, Joseph G.
中科院分区：
文献类型：
--
作者：
Simmons, Peter A.;Vehige, Joseph G.
目的：我们报告了3项研究的结果，以评估1.0%羧甲基纤维素（CMC）中粘度人工泪液与目前市场上销售的低粘度泪液的性能。方法：首先，对39例轻度至中度干眼症患者进行单中心、双盲、随机、交叉研究，比较中黏度泪液与低黏度泪液对眼保护指数（OPI）的影响。其次，一项为期1个月、两组、平行、随机、双盲的临床研究评估了103名轻度至中度干眼症患者的干眼客观体征和主观症状。第三，在为期1个月的家庭使用测试中，465名人工泪液使用者将中粘度泪液或当前低粘度泪液与他们当前的人工泪液进行了比较。结果：OPI研究显示，在滴入中黏度撕裂液后，撕裂破裂时间延长，OPI改善至少20分钟。低粘度泪液在5 ~ 10分钟内表现出改善。1个月的临床研究显示，治疗1周后染色和干眼症状明显减轻，中等粘度组1个月后染色进一步减少。与低粘度撕裂相比，中粘度撕裂提供了更多的模糊报告，但总体可接受性相同。家庭使用测试显示了中等粘度撕裂的普遍可接受性，包括更多的受试者表示，与之前的低粘度撕裂相比，需要更少的频率。结论：1% CMC中粘度泪液滴入后对眼表具有保护作用，可显著减轻干眼症状和体征。与低粘度泪液相比，改善更大。中粘度人工撕裂在舒适性、持续时间和普遍可接受性方面获得了良好的评价。
Purpose: We report the results of 3 studies conducted to evaluate the performance of a 1.0% carboxymethylcellulose (CMC) mid-viscosity artificial tear compared to currently marketed low-viscosity tears.Methods: First, a single-center, double-masked, randomized, crossover study was performed to compare the effect on the Ocular Protection Index (OPI) of the mid-viscosity tear compared to low-viscosity tears in 39 subjects with mild to moderate dry eye. Second, a 1-month, 2-arm, parallel, randomized double-masked clinical study assessed objective signs and subjective symptoms of dry eye in 103 subjects with mild to moderate dry eye. Third, in a 1-month home-use test, 465 artificial tear users compared the mid-viscosity tear or a current low-viscosity tear to their current artificial tear.Results: The OPI study showed prolonged tear breakup time and improved OPI for at least 20 minutes after instillation of the mid-viscosity tear. The low-viscosity tears showed improvements for 5 to 10 minutes. The 1-month clinical study showed a significant reduction in staining and dry eye symptoms after 1 week of treatment, with a further reduction in staining after 1 month in the mid-viscosity group. Subjects provided more reports of blur with the mid-viscosity tear than with a low-viscosity tear, but equivalent overall acceptability. The home use test showed general acceptability of the mid-viscosity tear, including more subjects indicating that it was needed less frequently than their prior low-viscosity tear.Conclusions: This 1% CMC mid-viscosity tear showed protection of the ocular surface after instillation and significant reduction in signs and symptoms of dry eye. Improvements were greater than with low-viscosity tears. The mid-viscosity artificial tear was rated well in comfort, duration of benefit, and general acceptability.