NCT06424444已完成3 期
A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 421
- 试验地点
- 1
- 主要终点
- Subject-reported ocular discomfort score over Week 1 to Week 6
研究概览
简要总结
A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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;
- •written informed consent and sign the Health Information Portability and Accountability Act (HIPAA) form;
- •history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
排除标准
- •ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;
- •contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the trial;
- •eye drops within 2 hours of Visit 1;
- •laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- •topical ocular cyclosporine, lifitegrast, corticosteroid, or any other topical ocular prescription medication within 90 days of Visit 1
研究组 & 干预措施
Reproxalap Ophthalmic Solution (0.25%)
Experimental
干预措施: Reproxalap ophthalmic solution (0.25%) (Drug)
Vehicle Ophthalmic Solution
Placebo Comparator
干预措施: Vehicle ophthalmic solution (Drug)
结局指标
主要结局
Subject-reported ocular discomfort score over Week 1 to Week 6
时间窗: From Day -14 to Day 43
Measured using a 0 - 100 visual analog scale where 0 is "no discomfort" and 100 is "maximal discomfort"
次要结局
未报告次要终点
研究者
研究点 (1)
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