NCT01741987已完成不适用
An Effectiveness of Osmoprotective Containing Lubricants in Dysfunctional Tear Syndrome (DTS) and Post Refractive Surgery Patients
Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- patients satisfaction with osmoprotective lubricant on different types DTS.
研究概览
简要总结
The purpose of this project is to determine the effectiveness of an eyewash osmoprotective lubricant comparing to castor oil containing and non-osmoprotective lubricants in different types of DTS and post refractive surgery patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients willing and able to comply with the protocol who are not planning changes in diet, topical or systemic drugs during the course of study.
- •DTS all the patients will be diagnosed for mild to moderate evaporative dry eye as defined by following criteria that will be given by Outcome measurements:
- •Break up time. 2.
- •Lissamine green staining. 2.
- •OSDI and Patient Symptomatology Questionnaire.
- •The patients, whose are going to be submitted for refractive surgery.
排除标准
- •Any patient with punctual occlusion or punctual plugs.
- •Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, history of retinal detachment, concurrent contact lens use during trial period,
- •Patients with glaucoma, anterior membrane dystrophy, active trichiasis or any eyelid globe malposition abnormality.
- •Patients with Epiphora.
- •Patients must not have participated in any investigational therapeutic drug or device trial within the 30 days prior to their start date for this trial.
- •Any patient suffering from organic brain syndromes or major psychiatric disorder that would interfere with compliance or subjective reporting will be discouraged from participating in this trial.
结局指标
主要结局
patients satisfaction with osmoprotective lubricant on different types DTS.
时间窗: 3 months
次要结局
- Physician satisfaction with Optive®(3 months)
- Our purpose is to determine the differential effects of Optive® castor oil Endura ® on different types DTS.(3 months)
研究者
Rossen Mihaylov Hazarbassanov, MD, PhD
MD
Federal University of São Paulo
研究点 (1)
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