NCT03216096已完成1 期
A Prospective, Open Label, One-arm, 4-weeks Study Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease -Phase 1 Study in Dry Eye Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Corneal fluorescein staining score
研究概览
简要总结
The objective of this study is to assess safety and efficacy of DE-089 ophthalmic solution in patients with dry eye disease in Taiwan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6-month dry eye history
排除标准
- •Diagnosed with Stevens-Johnson Syndrome or ocular pemphigoid
- •Diagnosed with keratoconjunctival chemical burns or thermal burn
- •Eye disease other than dry eye disease which needs treatment
- •Allergic conjunctivitis that may possibly be aggravated during the clinical study and inappropriate for efficacy evaluation
- •Those who need to wear contact lenses during the clinical study
- •Those who are considered inappropriate for this study by the investigator or subinvestigators
研究组 & 干预措施
3% DE-089 ophthalmic solution
Experimental
干预措施: Placebo ophthalmic solution and 3% DE-089 ophthalmic solution (Drug)
结局指标
主要结局
Corneal fluorescein staining score
时间窗: Week 4
Change in corneal fluorescein staining score at week 4/ at the time of discontinuation
次要结局
未报告次要终点
研究者
研究点 (2)
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