NCT04222712已完成1 期
A Randomized, Double-Masked, Dose-Ranging Study to Evaluate the Safety and Tolerability of TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis.
Tarsier Pharma2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Assessment of Both Systemic and Ocular Adverse Events
研究概览
简要总结
The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Able to provide informed consent, follow instructions and complete all required study visits for the duration of the study.
- •Diagnosed with active non-infectious anterior uveitis requiring an increase or initiation of topical steroids for management of ocular inflammation.
- •An eligible subject must have:
- •Non-infectious active anterior uveitis with anterior chamber cells Grade 2 or Grade 3, as specified per protocol.
- •Must have vision ≥ 20/40 in the non-study eye.
- •Use adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol.
排除标准
- •Any form of infectious uveitis
- •Active retinitis
- •Cancer or melanoma that is actively treated with immunotherapy
- •Pregnancy / lactation
- •Receiving specific medication/interventions as specified per protocol
研究组 & 干预措施
TRS01 low dose
Experimental
干预措施: TRS01 eye drops (Drug)
TRS01 high dose
Experimental
干预措施: TRS01 eye drops (Drug)
结局指标
主要结局
Assessment of Both Systemic and Ocular Adverse Events
时间窗: 10 weeks
Number of patients experiencing Adverse Events during the study
次要结局
未报告次要终点
研究者
研究点 (2)
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