NCT00364091已完成3 期
A Multi-Center, Randomized, Double-Masked Parallel Group Study Evaluating the Efficacy, Safety, and QOL of R89674 0.25% Ophthalmic Solution Compared to Vehicle or an Active Control in a Modified Model of Environmental Seasonal Allergic Conjunctivitis
Vistakon Pharmaceuticals6 个研究点 分布在 1 个国家目标入组 365 人开始时间: 2006年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 365
- 试验地点
- 6
- 主要终点
- Ocular itching and redness scores at defined timepoints
研究概览
简要总结
The purpose of this summary is to evaluate the efficacy and safety of R89674 0.025% ophthalmic solution compared with placebo or an active control in subjects with seasonal allergic conjunctivitis
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of positive diagnostic test for ragweed within the past 2 years;
- •positive bilateral response to ragweed as induced by conjunctival allergen challenge
排除标准
- •ocular infection;
- •history of retinal detachment, diabetic neuropathy, or any progressive retinal disease;
- •moderate to severe asthma;
- •dry eye syndrome;
- •history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal or autoimmune disease;
- •pregnancy or lactation
结局指标
主要结局
Ocular itching and redness scores at defined timepoints
次要结局
- QOL, severity of chemosis & redness, ocular itching and redness scores at defined timepoints
研究者
研究点 (6)
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