KCT0000517已完成未知
Placebo controlled, Dose-Response, Randomized, Double blind, Phase II Study to Evaluate the Efficacy and Safety of DA-6034 Eye Drops in Patients with Dry Eye Syndrome
Dong-A Pharm0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •(1)Age=20
- •(2)Dry eye symptoms(irritation, foreign body sensation, burning, mucus discharge, blurring, itching, photophobia, tird or heavy feeling, pain) for more than 6 months
- •(3)Fluorescein corneal staining score = 4 and Schirmer test I = 7mm in same eye
- •(4)Corrected vision = 0.2 in both eye
- •(5)Have given a written, informed consent
排除标准
- •(1)Ocular disorder that may confound interpretation of study results
- •(2)Current treatment for glaucoma or IOP over 25mmHg
- •(3)Ocular surgery history within 1 year
- •(4)Other malignancy history or uncontrolled severe disease within 5 years
- •(5)Use of systemic immunosuppressive therapies within 3 months
- •(6)Use of opthalmic cyclosporin, opthalmic steroid within 4 weeks
- •(7)Received any other investigational drugs within 4 weeks
- •(8)Subjects who are willing to wear contact lenses during study participation
- •(9)Pregnant or lactating women
- •(10)Other unsuitable cases as Investigator's discretion
研究者
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