NCT02595606Unknown4 期
0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ocular surface disease index
研究概览
简要总结
A randomized parallel controlled study was designed to compare the efficacy of 0.3% Sodium Hyaluronate in the treatment of Dry Eye of diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •medical history of diabetes
- •diagnosed with proliferative diabetic retinopathy
- •diagnosed with dry eye
- •not involvement in other drug experiment in the past 2 weeks
- •vision acuity better than 0.1
- •no local drug using history or with at least 2 weeks blanking period
排除标准
- •allergy to any of the drug ingredient
- •being or going to be pregnant or in lactation period
- •with any other eye disease or other serious disease which might affect the trial or could not get in follow-up
- •with any eye surgery history in the past six months
- •usage of hormone for replacement therapy
研究组 & 干预措施
treatment group
Experimental
treatment with 0.3% Sodium Hyaluronate, by five times a day, one or two drop each time
干预措施: 0.3% Sodium Hyaluronate (Drug)
结局指标
主要结局
ocular surface disease index
时间窗: up to 2 months
pre-,1,4,8 weeks after the initiation of the study(the use of drug for experimental group)
次要结局
- conjunctival goblet cells density(up to 2 months)
- corneal fluorescein staining assessment(up to 2 months)
- tear break up time(up to 2 months)
- Schirmer' test(up to 2 months)
研究者
Wang Zhichong
cornea department chief
Sun Yat-sen University
研究点 (1)
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