AGN-229666 for the Treatment of Allergic Conjunctivitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 90
- 主要终点
- Ocular Itching Score at Day 1
研究概览
简要总结
This study will evaluate the safety and efficacy of AGN-229666 for the treatment 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
- 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
- •Willing to discontinue wearing contact lenses during the study period
排除标准
- •Use of nicotine products during the study period
- •Presence of active eye infection (bacterial, viral, or fungal)
- •History of an ocular herpetic infection
- •Eye surgery intervention within 3 months and/or a history of refractive surgery within the past 6 months
研究组 & 干预措施
AGN-229666 Dose A
One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
干预措施: AGN-229666 (Drug)
AGN-229666 Dose B
One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
干预措施: AGN-229666 (Drug)
vehicle of AGN-229666
One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
干预措施: vehicle of AGN-229666 (Other)
结局指标
主要结局
Ocular Itching Score at Day 1
时间窗: Day 1
The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.
次要结局
- Ocular Itching Score at Day 15(Day 15)
- Conjunctival Hyperemia Score(Day 1)