A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 157
- 主要终点
- Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0
研究概览
简要总结
This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™ (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular itching 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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of ocular allergies within the past 24 months.
- •Able to avoid wearing contact lenses for at least 72 hours prior to and during the study trial period.
排除标准
- •Any presence of active ocular infection or history of an ocular herpetic infection.
- •Ocular surgery within 3 months prior to the first visit or refractive surgery within the past 6 months.
- •Have any planned surgery during the study or 30 days after the study.
研究组 & 干预措施
Lastacaft®
One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
干预措施: Alcaftadine 0.25% (Drug)
Pataday™
One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
干预措施: Olopatadine 0.2% (Drug)
Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)
One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
干预措施: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3% (Drug)
结局指标
主要结局
Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0
时间窗: Day 0 at 3 Minutes Post Challenge
Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.
次要结局
- Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0(Day 0)
- Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0(Day 0)
- Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0(Day 0)
- Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0(Day 0)
- Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0(Day 0)
- Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0(Day 0)
- Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0(Day 0)
- Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0(Day 0)
- Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0(Day 0)
- Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0(Day 0)