NCT00370747已完成2 期
Efficacy and Safety of Ecabet Ophthalmic Solution for the Treatment of Dry Eye Syndrome
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
- 162
- 主要终点
- Ocular signs and Symptoms
研究概览
简要总结
The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome
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
- Double
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
- •Male/female at least 18 years of age
- •Agree to avoid disallowed medications
- •Have a diagnosis of dry eye
排除标准
- •Have chronic systemic inflammation
- •Have active seasonal ocular allergies
研究组 & 干预措施
Ecabet
Experimental
Ophthalmic solution in the Study eye four times daily for 90 days.
干预措施: Ecabet (Drug)
Placebo
Placebo Comparator
Ophthalmic solution in the Study eye four times daily for 90 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Ocular signs and Symptoms
时间窗: 90 days
ocular signs, including corneal and conjunctival staining, tear film breakup time and blink rate, and ocular symptoms, including burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness or blurriness, photophobia, photopsia, and eye discomfort
次要结局
- Ocular Surface Disease Index (OSDI)(90 days)
研究者
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