A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Phase 2, Evaluation of the Safety and Efficacy of VSJ-110 Ophthalmic Solution in the Treatment of Allergic Conjunctivitis Using an Allergen Challenge Model
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Ocular Itching as Measured by Self-reported Numerical Scales
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of allergic conjunctivitis using an antigen challenge model
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, Care Provider)
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
- •At least 18 years of age of either gender and any race
- •Able to provide written informed consent and sign the HIPAA form
- •Willing and able to follow all instructions and attend all study visits
排除标准
- •Able and willing to avoid all disallowed medications during washout and study period
研究组 & 干预措施
VSJ-110 Solution
干预措施: VSJ-110 (Drug)
Placebo Solution
干预措施: Placebo (Drug)
结局指标
主要结局
Ocular Itching as Measured by Self-reported Numerical Scales
时间窗: 16 hours, 8 hours, and 15 minutes post-treatment
Change from baseline in ocular itching evaluated by the subject at 3(±1), 5(±1), and 7(±1) minutes post allergen challenge (0-4 scale, with a higher number indicating more itching)
Conjunctival Redness as Measured by Investigator Assessed Numerical Scales
时间窗: 16 hours, 8 hours, and 15 minutes post-treatment
Change from baseline in conjunctival redness evaluated by the investigator at 7 (±1), 15 (±1), and 20 (±1) minutes post allergen challenge (0-4 scale, with a higher number indicating more redness)
次要结局
- Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales(16 hours, 8 hours, and 15 minutes post-treatment)