NCT05042609已完成3 期
A Phase 3 Randomized, Active-Controlled, Double-Masked Study to Evaluate the Safety and Efficacy of TRS01 Eye Drops in the Treatment of Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma
Tarsier Pharma59 个研究点 分布在 3 个国家目标入组 142 人开始时间: 2021年9月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 59
- 主要终点
- Anterior Chamber Cell (ACC) grade on Day 28
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops compared to active comparator in subjects with active non-infectious anterior uveitis with or without uveitic glaucoma
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
- 0 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At sites in the US: Male or female up to and including 75 years of age (including all pediatric age groups). At sites in the Europe: Male or female between 18 and 70 years of age, inclusive.
- •Diagnosed with active non-infectious anterior uveitis with anterior chamber cell Grade 2 (6-15 cells) or Grade 3 (16-30 cells) in the study eye that are without any treatment or with Stable Medical Therapy requiring further treatment.
- •Have Best Corrected Visual Acuity (BCVA) vision ≥ 65 letters in the non-study eye using Early Treatment Diabetic Retinopathy Study (ETDRS).
排除标准
- •Pregnant or breastfeeding females or females.
- •History of or active significant ocular disease in either eye.
- •Uncontrolled intraocular pressure (IOP; defined as >27mmHg) or narrow angle glaucoma in either eye and/or are at risk of angle closure with dilating.
- •Poor posterior view due to limitation of dilation or media opacity that limits ability to examine the posterior segment.
- •Cancer or melanoma that is actively treated with immunotherapy.
- •Certain clinically significant systemic diseases or conditions.
- •Receiving specific medication/interventions as specified per protocol.
研究组 & 干预措施
TRS01
Experimental
干预措施: TRS01 (Drug)
Active comparator
Active Comparator
干预措施: FDA approved steroid eye drop (masked) (Drug)
结局指标
主要结局
Anterior Chamber Cell (ACC) grade on Day 28
时间窗: 28 days
For FDA submission: the proportion of subjects with Anterior Chamber Cell (ACC) Grade=0 (0 cells) on Day 28 in the study eye. For submission to European Medicines Agency (EMA) related countries: the proportion of subjects with ACC Grade = 0 or 1 on Day 28 in the study eye.
次要结局
- Anterior Chamber Cell (ACC) grade on Day 21(21 days)
- Change from baseline in ACC Grade on Day 21.(21 days)
- Change from baseline (Day 1) in ACC Grade on Day 28 in the study eye(28 days)
研究者
研究点 (59)
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