Dose-Response Study of DE-089 Ophthalmic Solution in Patients With Dry Eye -Late Phase II Confirmatory Study-
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Mean Change in Fluorescein Staining Score From Baseline
研究概览
简要总结
Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in patients with dry eye, using a multicenter, randomized, double-blind, parallel group comparison study, and the optimal concentration is determined.
研究设计
- 研究类型
- Interventional
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
- •Those who show:
- •Keratoconjunctival disorder confirmed with vital dye staining
- •Abnormal Schirmer score results
排除标准
- •Eye disease that needs therapy other than that for dry eye
- •Those who need to wear contact lenses during the clinical study
研究组 & 干预措施
High concentration
干预措施: DE-089 ophthalmic solution (Drug)
Low concentration
干预措施: DE-089 ophthalmic solution (Drug)
Placebo
干预措施: Placebo ophthalmic solution (Drug)
结局指标
主要结局
Mean Change in Fluorescein Staining Score From Baseline
时间窗: Baseline and 4-week (discontinued(LOCF))
Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better. The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.
次要结局
未报告次要终点