NCT00788229已完成2 期
A Phase II, Randomized, Double-Blind, Clinical Trial to Evaluate the Efficacy and Safety of DHP-101, DHP-300, DHP-500 in Patients With Dry Eye Syndrome
Dhp Korea Co., Ltd.1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Tear Break Up Time (TBUT)
研究概览
简要总结
The purpose of this study is to determine whether artificial tears are safe and effective in the treatment of Dry Eye Syndrome.
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
- 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
- 否
入选标准
- •Male and female adults aged 18 years and over.
- •Subjects should diagnosed as dry eye syndrome in both eyes or one eye, keratoconjunctivitis sicca (KCS), or should have at least a 3-month history diagnosed as dry eye syndrome due to Sjögren syndrome.
- •Subjects must agree to discontinue all artificial tears from Screening for 2 weeks
- •Subjects must discontinue lens wear one week before Screening and agree not to wear contact lenses during the entire study.
- •Subjects who have taken Restasis® are eligible for inclusion if they have not used Restasis® during the 4 weeks prior to Screening
- •Subjects must provide signed informed consent prior to participation in any study-related procedures
- •Subjects who dose not Participate in same clinical trial within 6 month prior to Screening.
排除标准
- •Pregnancy or lactation.
- •Females of childbearing potential who are not using systemic contraception,are not postmenopausal (≥ 1 year), or are not surgically sterilized.
- •Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
- •Any active inflammation of the eye not due to KCS
- •Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study medication.
研究组 & 干预措施
1. Study Drugs
Experimental
干预措施: AT01 (Drug)
2. Study Drug
Experimental
干预措施: AT02 (Drug)
3. Study Drug
Experimental
干预措施: AT03 (Drug)
4. Placebo
Placebo Comparator
干预措施: AT04 (Drug)
结局指标
主要结局
Tear Break Up Time (TBUT)
时间窗: 12weeks
次要结局
- Fluorescein staining, schirmer test, OSDI, VAS(12 weeks)
研究者
研究点 (1)
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