A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 127
- 主要终点
- Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16
研究概览
简要总结
This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to artificial tears (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 eye allergies within the past 24 months
- •Willing to not wear contact lenses at least 72 hours prior to the study start and during the study period
排除标准
- •Current eye infection
- •Eye surgery within 3 months or vision correction surgery within 6 months
- •Any planned surgery during the study or 30 days after the study
研究组 & 干预措施
LASTACAFT® (alcaftadine 0.25%)
One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
干预措施: alcaftadine 0.25% ophthalmic solution (Drug)
Pataday™ (olopatadine 0.2%)
One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
干预措施: olopatadine 0.2% ophthalmic solution (Drug)
Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)
One drop of placebo instilled in each eye at Day 0 and Day 14.
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 at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16
时间窗: Day 0 Hour 16
Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.
Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24
时间窗: Day 14 Hour 24
Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.
次要结局
- Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24(Day 14 Hour 24)
- Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24(Day 14 Hour 24)
- Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24(Day 14 Hour 24)
- Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24(Day 14 Hour 24)
- Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24(Day 14 Hour 24)
- Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24(Day 14 Hour 24)