NCT00241319已完成3 期
A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Evaluation of the Onset and Duration of Action of R89674 0.25% Ophthalmic Solution in Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
Vistakon Pharmaceuticals5 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2005年10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
- 150
- 试验地点
- 5
- 主要终点
- Ocular itching and conjunctival redness post challenge
研究概览
简要总结
The purpose of this study is to establish the efficacy of R89674 0.25% ophthalmic solution compared with placebo in alleviating the signs and symptoms of conjunctival allergen challenge-induced 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 ocular allergies and a positive skin test reaction to cat hair,
- •cat dander, grasses, ragweed, and/or trees within the past 24 months;
- •calculated best-corrected visual acuity of 0.6 logMar or better in each eye; - positive bilateral conjunctival allergy challenge reaction
排除标准
- •narrow angle glaucoma,
- •clinically significant blepharitis, follicular conjunctivitis, iritis
- •pterygium or diagnosis of dry eye
- •ocular surgical intervention within 3 months
- •history of refractive surgery within 6 months
- •known history of retinal detachment, diabetic retinopathy, or progressive retinal disease
- •presence of active ocular infection positive history of an ocular herpetic infection
- •preauricular lymphadenopath manifest signs or symptoms of clinically active allergic conjunctivitis
结局指标
主要结局
Ocular itching and conjunctival redness post challenge
次要结局
- Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge
研究者
研究点 (5)
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