Double-masked Comparison Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (Multi-center Study, in Comparison to 0.1% Sodium Hyaluronate Ophthalmic Solution) - Phase III Confirmatory Study -
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 332
- 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
To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in fluorescein staining score, and is superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group comparison study. Safety profile will likewise be compared.
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
3% DE-089
干预措施: 3% DE-089 ophthalmic solution (Drug)
0.1% HA
干预措施: 0.1% sodium hyaluronate 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.
Mean Change in Rose Bengal Staining Score From Baseline
时间窗: Baseline and 4-week (discontinued (LOCF))
Rose bengal staining were scored according to the protocol by Shimmura et al. The ocular surface was divided into 5 zones: nasal and temporal conjunctival, and upper, middle, and lower corneal areas. A staining score between 0 and 3 points was used in each zone, with the minimum and maximum total staining scores ranging between 0 and 15 points.0 is better. The degree of staining with Rose bengal 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