A Single-Center, Randomized, Double-Masked, Vehicle and Active-Controlled, Dose-Ranging Phase 2 Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model (Ora-CAC®)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1
研究概览
简要总结
To evaluate the efficacy and safety of two concentrations of PRT-2761 as a topical ophthalmic solution for the treatment of the signs and symptoms of acute and chronic 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
- •be at least 18 years old
- •be willing and able to avoid all disallowed medications and contact lenses
- •must have a pregnancy test if of childbearing potential
- •must be able to read an eye chart from 10 feet away
排除标准
- •must not have any allergies to the study medications
- •must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
- •must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial
研究组 & 干预措施
PRT-2761 0.5%
干预措施: PRT-2761 0.5% (Drug)
PRT-2761 1%
干预措施: PRT-2761 1% (Drug)
Patanol
干预措施: Patanol (Drug)
Pred-forte
干预措施: Pred-forte (Drug)
PRT-2761 0%
干预措施: PRT-2761 0% (Drug)
结局指标
主要结局
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1
时间窗: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1.
Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point.
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15
时间窗: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.
Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point.
Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15
时间窗: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15
Ocular Itching was assessed by the subjects using a 0 to 4 point scale(0=none (best/no itching) to 4=severe (worst/most itching)). The ocular itching was averaged across all subjects at each time point.
Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1
时间窗: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1
Ocular Itching was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no itching) to 4=severe (worst/most itching). The ocular itching was averaged across all subjects at each time point.
次要结局
未报告次要终点