The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap 0.25% Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 422
- 试验地点
- 1
- 主要终点
- Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))
研究概览
简要总结
The RENEW Trial is a Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap 0.25% Ophthalmic Solution 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
- Triple (Participant, Care Provider, 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 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, including active blepharitis; meibomian gland dysfunction (MGD); lid margin inflammation; or active ocular allergies that require therapeutic treatment, or, in the opinion of the investigator may interfere with the assessment of the safety or efficacy of reproxalap or vehicle;
- •Have or 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 ophthalmic cyclosporine or lifitegrast 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;
- •Have used temporary or permanent punctal plugs within 30 days prior to Visit 1 or anticipate their use during the study period
研究组 & 干预措施
Reproxalap Ophthalmic Solution (0.25%) QID
干预措施: Reproxalap Ophthalmic Solution (0.25%) QID (Drug)
Vehicle Ophthalmic Solution QID
干预措施: Vehicle Ophthalmic Solution QID (Drug)
Reproxalap Ophthalmic Solution (0.25%) QID to BID
干预措施: Reproxalap Ophthalmic Solution (0.25%) QID to BID (Drug)
Vehicle Ophthalmic Solution QID to BID
干预措施: Vehicle Ophthalmic Solution QID to BID (Drug)
结局指标
主要结局
Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))
时间窗: The efficacy assessment period (Day 1 through 85) was assessed at Weeks 1, 2, 4, 6, 8, 10, and 12; baseline was Day 1.
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular dryness score VAS (0 = no discomfort - 100 = maximal discomfort), where a higher score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline calculated using baseline score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.
Fluorescein Nasal Region Score (0 = None - 4 = Severe)
时间窗: The efficacy assessment period (Day 15 through 85) was assessed at Weeks 2, 4, 6, 8, 10, and 12; baseline was Day 1.
Change from baseline comparison of reproxalap to vehicle for fluorescein staining of the nasal region (0 = none - 4 = severe), where a higher score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline calculated using baseline fluorescein nasal score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.
次要结局
未报告次要终点