A Phase 2 Randomized, Investigator-Masked, Comparator-controlled Trial to Evaluate the Safety and Efficacy of NS2 Eye Drops in Patients With Anterior Uveitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 15
- 主要终点
- Anterior Chamber Cell Grade at Week 8
研究概览
简要总结
This is a randomized, multi-center, investigator masked, comparator controlled study. The purpose of this study is to determine the efficacy and safety of NS2 in patients with non-infectious acute anterior uveitis. Subjects will be randomized 1:1:1 to receive multiple doses of NS2 0.5%, NS2 0.5% and Pred Forte® 1%, or Pred Forte® 1%.
Free aldehydes are thought to be related to inflammatory diseases such as uveitis. NS2, a small molecule aldehyde trap, may decrease inflammation by lowering aldehyde levels.
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 (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
- •Non-infectious anterior uveitis
- •Grade 1 - Grade 3 anterior chamber cell count
- •Subjects must have Intraocular pressure <25 mmHg at baseline and may only administer a maximum of 1 topical medication to control Intraocular pressure in the study eye.
- •Visual acuity ≥ 20/200 in the study eye
排除标准
- •Severe/serious ocular pathology
- •Active intermediate or posterior uveitis.
- •Previous anterior uveitis episode in the study eye within 4 weeks of Visit 1
- •Oral corticosteroids within 14 days of Visit 1
- •Intravitreal or sub-Tenon corticosteroid treatment in the study eye within the past 6 months.
研究组 & 干预措施
NS2
NS2 ophthalmic drops (0.5%) in the affected eye
干预措施: NS2 (Drug)
NS2 and Pred Forte
NS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye
干预措施: NS2 (Drug)
NS2 and Pred Forte
NS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye
干预措施: Prednisolone acetate ophthalmic suspension (1%) (Drug)
Pred Forte
Prednisolone acetate ophthalmic suspension (1%) in the affected eye
干预措施: Prednisolone acetate ophthalmic suspension (1%) (Drug)
结局指标
主要结局
Anterior Chamber Cell Grade at Week 8
时间窗: The efficacy assessment period was assessed at Week 8; baseline was Day 1.
Change from baseline comparison of NS2 ophthalmic drops (0.5%), NS2 (0.5%) and Pred Forte® (0.1%) ophthalmic drops, and Pred Forte® (1%) ophthalmic drops on an anterior chamber cell grade scale of 0 to 4 (0 = absent, 4 = severe). The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor.
次要结局
未报告次要终点