AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 312
- 主要终点
- Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of AL-38583 in the treatment of the signs of inflammation associated with 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
- •Presence of signs and symptoms of ocular inflammation in both eyes.
- •Have a positive CAC response at Visit
- •Able to avoid the use of disallowed medications as well as contact lens wear for the specified period prior to Visit 1, and for the duration of the study.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Have known history or presence of persistent dry eye syndrome.
- •Presence of any ophthalmic abnormality that may affect the study outcomes.
- •Have a history of moderate to severe allergic asthma reaction to mountain cedar or the perennial allergens used in the study.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AL-38583 0.01%
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
干预措施: AL-38583 ophthalmic solution (Drug)
AL-38583 0.05%
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
干预措施: AL-38583 ophthalmic solution (Drug)
AL-38583 0.2%
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
干预措施: AL-38583 ophthalmic solution (Drug)
AL-38583 Vehicle
AL-38583 ophthalmic solution vehicle, 1 drop instilled in each eye 3 times per day for 2 weeks
干预措施: AL-38583 ophthalmic solution vehicle (Drug)
MAXIDEX
Dexamethasone ophthalmic suspension, 0.1%, 1 drop instilled in each eye 3 times per day for 2 weeks
干预措施: Dexamethasone ophthalmic suspension, 0.1% (Drug)
结局指标
主要结局
Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores
时间窗: Day 14
次要结局
- Mean daily diary ocular redness scores(2 week period between Day 0 and Day 14)