A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects With Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness.
研究概览
简要总结
A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects with Dry Eye Disease
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
- •Be at least 18 years of age of either gender and any race;
- •Have a reported history of dry eye for at least 6 months prior to Visit 1;
- •Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;
排除标准
- •Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
- •Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
- •Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
- •Have used any eye drops within 2 hours of Visit 1;
- •Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- •Have used cyclosporine 0.05% or lifitigrast 5.0% ophthalmic solution within 90 days of Visit 1;
- •Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
- •Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
研究组 & 干预措施
Reproxalap Ophthalmic Solution (0.25%)
干预措施: Reproxalap Ophthalmic Solution (0.25%) (Drug)
Reproxalap Ophthalmic Solution (0.1%)
干预措施: Reproxalap Ophthalmic Solution (0.1%) (Drug)
Vehicle Ophthalmic Solution
干预措施: Vehicle Ophthalmic Solution (Drug)
结局指标
主要结局
Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness.
时间窗: Efficacy assessment period (Day 1 through Day 85) - assessed on Days 1, 15, 29, 57, and 85.
Change from baseline comparison of ADX-102 to Vehicle on the Ora Calibra® Discomfort \& 4-Symptom Questionnaire (0 = least, 5 = most) for dryness across all time points. The intervention was administered bilaterally. The Least Squares Mean (Standard Error) was derived from Mixed Model Repeated Measure for change from baseline calculated using baseline score, visit, treatment, and visit-by-treatment interaction.
次要结局
未报告次要终点