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临床试验/NCT02992392
NCT02992392Unknown不适用

Comparison of the Clinical Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年12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
发起方
入组人数
50
试验地点
1
主要终点
scale of noninvasive tear breakup time

研究概览

简要总结

With the potential to address evaporative dry eye, Liposic and Tears Naturale Forte have been developed in which phospholipid liposomes are delivered to the tear film via the surface of the closed eyelid. This study compare the effects of Liposic and Tears Naturale Forte application on the lipid and stability of the tear film in dry eye 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
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Minimum age of 20 years(range from 20 year to 25 years)
  • The value of OSDI is over 12
  • NBUT is less 5 seconds
  • Schirmer 1 test is less 10mm
  • The basical lipid layer grade is 1-2

排除标准

  • Any corneal,conjunctival, or eyelid abnormalities; conjunctivitis; current ocular infection; photophobia that may cause reflex tearing or difficulty in evaluating the patient's lipid layer;
  • Known allergic sensitivity to any of the ingredients in Liposic or Tears Naturale Forte

研究组 & 干预措施

Liposic

Experimental

Liposic was applied to one eye of patients in this group

干预措施: Liposic (Drug)

Tears Naturale Forte

Experimental

Tears Naturale Forte was applied to one eye of patients in this group

干预措施: Tears Naturale Forte (Drug)

结局指标

主要结局

scale of noninvasive tear breakup time

时间窗: up to 3 months after tear substitutes apply

scale of Schirmer I test

时间窗: up to 3 months after tear substitutes apply

scale of corneal fluorescein staining

时间窗: up to 3 months after tear substitutes apply

lipid layer grade

时间窗: up to 3 months after tear substitutes apply

scale of tear meniscus height

时间窗: up to 3 months after tear substitutes apply

questionnaire of ocular surface disease index

时间窗: up to 3 months after tear substitutes apply

次要结局

  • subjective comfort(up to 3 months after tear substitutes apply)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xingwu Zhong, MD PhD

Professor

Sun Yat-sen University

研究点 (1)

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