Comparison of the Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- scale of tear meniscus height
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
- 是
入选标准
- •Age range from 20 year to 40 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 patien '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
Liposic was applied to one eye of patients in this group
干预措施: Liposic (Drug)
Tears Naturale Forte
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 tear meniscus height
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
scale of noninvasive tear breakup time
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
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)