NCT00836485已完成2 期
A Prospective, Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
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
- 122
- 试验地点
- 1
- 主要终点
- Ocular itching and bulbar conjunctival redness
研究概览
简要总结
This is a phase 2 study that will consist of 4 visits over a 5 week period. Drug will be evaluated using the conjunctival allergen challenge model of 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 (Participant, Investigator)
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
- •18 years of age of either sex and any race
- •positive history of ocular allergies and a positive skin test reaction to cat hair, cat dander, dog dander, grasses, ragweed, trees, dust mites, and/or cockroaches within the past 24 months
- •able and willing to avoid all disallowed medication for the washout period and during the study
排除标准
- •active ocular infection or skin condition
- •ocular surgery within the past 3 months
- •pregnancy or nursing
研究组 & 干预措施
1
Experimental
Ketotifen 4.0% Patch
干预措施: Ketotifen 4.0% Patch (Drug)
2
Placebo Comparator
Placebo Patch
干预措施: Placebo (Drug)
3
Active Comparator
Pataday(TM)
干预措施: Olopatadine 0.2% (Drug)
4
Placebo Comparator
Placebo eye drops
干预措施: Artificial tears (Drug)
结局指标
主要结局
Ocular itching and bulbar conjunctival redness
时间窗: Visit 3 and Visit 4
次要结局
- Nasal: Rhinorrhea; ear or palate pruritis; nasal pruritis; nasal congestion; and a composite score of all nasal symptoms(Visit 3 and Visit 4)
- Ocular: Ciliary, episcleral, and inferior palpebral conjunctival redness; chemosis; lid swelling; tearing; ocular mucous discharge(Visit 3 and Visit 4)
研究者
研究点 (1)
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