AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 140
- 主要终点
- Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale
研究概览
简要总结
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal or perennial allergic conjunctivitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese patients living in Japan with allergic conjunctivitis with itching and redness
- •Able and willing to discontinue wearing any contact lenses during the study period.
排除标准
- •Eye surgical intervention and/or a history of refractive surgery within 6 months
- •History of retinal detachment, diabetic retinopathy, or progressive retinal disease
- •Presence of active eye infection (bacterial, viral, or fungal)
- •History of an eye herpetic infection
- •Use of corticosteroids within 6 months or anticipated use during the study.
研究组 & 干预措施
AGN-229666
One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
干预措施: AGN-229666 (Drug)
结局指标
主要结局
Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale
时间窗: Baseline, Day 70
Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
次要结局
未报告次要终点