AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 240
- 主要终点
- Ocular Itching Score
研究概览
简要总结
This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese patients living in Japan with a history of allergic conjunctivitis.
排除标准
- •Presence of active eye infection (bacterial, viral, or fungal)
- •History of an eye herpetic infection.
研究组 & 干预措施
AGN-229666/Olopatadine
One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
干预措施: AGN-229666 (Drug)
AGN-229666
One drop of AGN-229666 in each eye on Days 1 and 15.
干预措施: AGN-229666 (Drug)
Vehicle
One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
干预措施: Vehicle to AGN-229666 (Drug)
Olopatadine
One drop of olopatadine in each eye on Days 1 and 15.
干预措施: Olopatadine (Drug)
AGN-229666/Olopatadine
One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
干预措施: Olopatadine (Drug)
AGN-229666/Vehicle
One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
干预措施: AGN-229666 (Drug)
AGN-229666/Vehicle
One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
干预措施: Vehicle to AGN-229666 (Drug)
结局指标
主要结局
Ocular Itching Score
时间窗: Days 1 and 15
Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged.
次要结局
- Conjunctival Hyperemia Score(Days 1 and 15)