A Phase III Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the CAC Model of Acute Allergic Conjunctivitis in Japanese Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 267
- 主要终点
- Mean Ocular Itching Score
研究概览
简要总结
The purpose of the study is to demonstrate safety and efficacy of Olopatadine 0.2% compared to its vehicle in Japanese subjects in the treatment of acute allergen-mediated conjunctivitis using the conjunctival allergen challenge (CAC) test.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Japanese ethnicity.
- •Seasonal Allergic Conjunctivitis--asymptomatic.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Manifest signs and symptoms of clinically active allergic conjunctivitis in either eye (>1 for redness in any of the 3 vessels beds - conjunctival, episcleral, ciliary - or itching >0) at the start of any visit.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Pataday+Pataday Vehicle
Olopatadine Hydrochloride Ophthalmic Solution 0.2%, 1 drop in 1 eye and Olopatadine 0.2% Vehicle in the contralateral eye
干预措施: Olopatadine 0.2% Vehicle (Drug)
Pataday+Pataday Vehicle
Olopatadine Hydrochloride Ophthalmic Solution 0.2%, 1 drop in 1 eye and Olopatadine 0.2% Vehicle in the contralateral eye
干预措施: Olopatadine Hydrochloride Ophthalmic Solution, 0.2% (Drug)
Patanol+Patanol Vehicle
Olopatadine Hydrochloride Ophthalmic Solution, 0.1%, 1 drop in 1 eye and Olopatadine 0.1% Vehicle in the contralateral eye
干预措施: Olopatadine Hydrochloride Ophthalmic Solution, 0.1% (Drug)
Patanol+Patanol Vehicle
Olopatadine Hydrochloride Ophthalmic Solution, 0.1%, 1 drop in 1 eye and Olopatadine 0.1% Vehicle in the contralateral eye
干预措施: Olopatadine 0.1% Vehicle (Drug)
结局指标
主要结局
Mean Ocular Itching Score
时间窗: Day 0 of treatment: 3, 5, and 10 minutes post CAC
次要结局
- Mean Total Redness Score(Day 0 of treatment: 3, 10, 20 minutes post-CAC)