NCT00445874已完成3 期
A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens as Compared to Placebo in the Prevention of Allergic Conjunctivitis in a Population of Allergic Contact Lens Wearers
Vistakon Pharmaceuticals7 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2007年2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
- 120
- 试验地点
- 7
- 主要终点
- Ocular itching
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of an anti-allergy drug with a contact lens compared to placebo in preventing ocular itching associated with allergic conjunctivitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 8 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 withing the past 24 months
- •Successful soft contact lens wearer who has frequently worn contact lenses for at least one month or more
排除标准
- •Active ocular infection
- •Clinically significant blepharitis
- •Follicular conjunctivitis
- •Pterygium
- •Narrow angle glaucoma
- •Dry eye dyndrome
- •Ocular surgery within past 6 months
- •Pregnancy or lactation
结局指标
主要结局
Ocular itching
次要结局
- Conjunctival, ciliary, and episcieral redness; chemosis and mucous discharge; tearing and lid swelling
研究者
研究点 (7)
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