NCT00831662已完成3 期
The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 490
- 主要终点
- Proportion of subjects that achieve clearing of fluorescein staining of the central cornea (NEI scale). Subjects must have a score of 0 on the NEI scale at Week 6 to be considered responders.
研究概览
简要总结
The purpose of this study is to confirm the safety and efficacy of diquafosol tetrasodium ophthalmic solution, 2% vs. placebo, in subjects with dry eye disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Have best corrected visual acuity in both eyes of at least +0.7 or better
- •Central corneal staining of 3 on the NEI scale
- •If female, are non-pregnant or non-lactating
- •Have a history of dry eye disease in both eyes
- •Have normal lid anatomy
排除标准
- •Unable to withhold the use of contact lenses during the study or 2 weeks prior to the study
- •Have had ocular surface surgery within the past year
- •Are considered legally blind in one eye
- •Have a serious medical condition which could confound study assessments
研究组 & 干预措施
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
Arm 1
Experimental
干预措施: Diquafosol tetrasodium ophthalmic solution, 2% (Drug)
结局指标
主要结局
Proportion of subjects that achieve clearing of fluorescein staining of the central cornea (NEI scale). Subjects must have a score of 0 on the NEI scale at Week 6 to be considered responders.
时间窗: 6 weeks
次要结局
- Proportion of subjects that achieve a 2-or-more-unit reduction of fluorescein staining of the central cornea (NEI scale)(6 weeks)
研究者
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