NCT00600288已完成3 期
A Multi-Center, Parallel-Group, Double-Masked, Randomized, Placebo-Controlled Study of the Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% and Placebo in Subjects With Dry Eye Disease
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
- 261
- 主要终点
- Change in fluorescein staining scores of the cornea
研究概览
简要总结
The purpose of this pilot study is to evaluate the effect of diquafosol tetrasodium Ophthalmic Solution, 2% in dry eye subjects.
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
- •Provide written informed consent prior to any study procedures being performed.
- •Have a best corrected visual acuity (BCVAof +0.7 or better.
- •Have a history of dry eye (keratoconjunctivitis sicca) in both eyes
- •Have ongoing dry eye disease, in the same qualifying eye or both eyes.
排除标准
- •Have previously had LASIK refractive surgery.
- •Use of topical ophthalmic medications, preps, gels and lid scrubs during study.
- •Have had penetrating intraocular surgery in the past 90 days.
- •Have had other ocular surface surgery (e.g., refractive, pterygium) within the past year.
- •Have a diagnosis of an on-going ocular infection, clinically significant blepharitis, lid margin inflammation, Stevens-Johnson syndrome or pemphigoid.
- •Any serious ocular systemic disease or uncontrolled medical condition.
- •Exposure to any investigational drug within 30 days of study start.
研究组 & 干预措施
1
Experimental
干预措施: diquafosol tetrasodium Ophthalmic Solution, 2% (Drug)
2
Placebo Comparator
干预措施: Non-preserved saline solution (Placebo) (Drug)
结局指标
主要结局
Change in fluorescein staining scores of the cornea
时间窗: 6 weeks
次要结局
- Safety and Tolerability(6 weeks)
研究者
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