A Phase 3, Randomized, Double-masked, Vehicle-controlled Trial to Evaluate the Safety and Efficacy of ADX-102 Ophthalmic Solution in Subjects With Non-infectious Anterior-uveitis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 26
- 主要终点
- Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells
研究概览
简要总结
A Phase 3, randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of ADX-102 ophthalmic solution in Subjects with non-infectious anterior-uveitis.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥ 18 years and ≤ 85 years.
- •Subjects with acute non-infectious anterior uveitis with onset of symptoms within the previous 2 weeks.
- •Best corrected visual acuity (BCVA) better than or equal to 35 letters in the study eye and 65 letters in the non-study eye using ETDRS testing.
排除标准
- •Have severe/serious ocular pathology in the study eye(s) which may preclude study completion, in the judgement of the Investigator.
- •Active intermediate or posterior uveitis in the study eye(s).
- •Previous anterior uveitis episode in the study eye ≤ 4 weeks prior to screening.
- •Have participated in another investigational device or drug study within 30 days prior to screening.
- •Participation in a prior ADX-102 study.
研究组 & 干预措施
ADX-102 Ophthalmic Solution (0.5%)
干预措施: ADX-102 Ophthalmic Solution (0.5%) (Drug)
Vehicle of ADX-102 Ophthalmic Solution
干预措施: Vehicle of ADX-102 Ophthalmic Solution (Drug)
结局指标
主要结局
Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells
时间窗: The efficacy assessment period was 4 weeks; baseline was defined as Day 1.
Time to clearance of anterior chamber cells was defined as the time from initiation of study drug to when a cell count of 0 was achieved and maintained (without cell count increases to \>0) to Week 4 and without rescue or discontinuation due to rescue prior to Week 4. Anterior chamber cell count is the number of cells visible within the anterior chamber of the eye, measured using a slit lamp and following SUN (Standardization of Uveitis Nomenclature) where a cell count \<1 is Grade 0 (absent) and a cell count of \>50 is Grade 4+ (severe).
次要结局
未报告次要终点