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临床试验/NCT02077231
NCT02077231已完成不适用

Study of Vitamin A and Carbomer in Comforting the Ocular Surface Irritations of Glaucoma Patients

Xiaodong Zhou0 个研究点目标入组 30 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
主要终点
change of the density of conjunctival goblet cells

研究概览

简要总结

Most of the patients under long application of anti-glaucoma eyedrops endure severe ocular surface irritation, which interrupt their quality of life a lot. Lots of studies aimed to search for new drugs for therapy. The investigators hypothesized that the artificial tears containing vitamin A or carbomer may be a great substitute. Both of the two drugs were in common use and had already been tested in animals.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed primary open-angle glaucoma or normal tension glaucoma patients with prostaglandin analogs treatment for more than one year.

排除标准

  • any systemic diseases which may cause ocular damage;
  • previous ocular trauma or surgery;
  • contact lens wear history in previous 6 months;
  • application of any artificial tears 3 months ago;
  • allergic to any of the drugs we used during examination.

研究组 & 干预措施

vitamin A palmitate eye gel

Experimental

0.1% vitamin A palmitate; Sinqi, Shenyang, China

干预措施: Vitamin A (Drug)

carbomer eye gel

Experimental

0.2% Carbomer 940; Bausch & Lomb, Aschheim, Germany

干预措施: carbomer eye gel (Drug)

结局指标

主要结局

change of the density of conjunctival goblet cells

时间窗: change from Baseline in goblet cell density at 6 months

次要结局

  • tear film parameters changes in patients(change from baseline in TBUT and Schirmer test at 6 months)
  • changes of ocular irritation in patients(change from baseline in OSDI scores at 6 months)

研究者

发起方
Xiaodong Zhou
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xiaodong Zhou

Professor of Ophthalmology

Shanghai Jinshan Hospital

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