NCT00799552已完成2 期
A Phase II, Multi-Center, Double-Masked, Randomized, Placebo Controlled, Study on the Safety and Efficacy of RX-10045 on the Signs and Symptoms of Dry Eye in Every Day Environmental Conditions and During Provocation Using the Controlled Adverse Environment (CAE) Model
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Corneal fluorescein staining and integrated subject diary data
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of RX-10045 to placebo for the treatment of the signs and symptoms of dry eye.
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
- •Be at least 18 years of age;
- •Have provided written informed consent;
- •Have a history of dry eye for at least 6 months prior to enrollment;
- •Have a history of use or desire to use eye drops for dry eye symptoms within the past 6 months;
- •Demonstrate a response when exposed to the CAE.
排除标准
- •Have an on-going ocular infection, or active ocular inflammation
- •Have worn contact lenses within 72 hours of Visit 1 or have anticipated use of contact lenses during the study;
- •Have contact lens-induced dry eye;
- •Have previously had laser in situ keratomileusis (LASIK) surgery;
- •Be using or have anticipated use of temporary punctual plugs during the study;
- •Have best corrected visual acuity > +0.7 in both eyes;
- •Be a woman who is pregnant, nursing or planning a pregnancy;
- •Have a known allergy and/or sensitivity to the test article or its components;
- •Be currently using any medication known to cause ocular drying that is not used on a stable dosing regimen for at least 30 days
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
RX-10045
Experimental
干预措施: RX-10045 (Drug)
结局指标
主要结局
Corneal fluorescein staining and integrated subject diary data
时间窗: 28 days
次要结局
- Changes in dry eye signs and symptoms(28 days)
研究者
研究点 (1)
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