NCT04222725已完成1 期
A Multicenter, Double-Masked, Randomized, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety of TRS01 Eye Drops in Participants With Post-surgical Inflammation
Tarsier Pharma5 个研究点 分布在 1 个国家目标入组 37 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
- 37
- 试验地点
- 5
- 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 and preliminary efficacy of TRS01 eye drops as compared to placebo on participants with ocular inflammation after cataract surgery.
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
- •Pre-operatively, individuals of either gender or any race will be eligible for study participation if they are:
- •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.
- •Scheduled for routine cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens (IOL) implantation, and not combined with any other surgery.
- •Have vision ≥ 20/200 in the non-study eye.
- •Able to self-administer eye drops (tested during screening by self-administration of "artificial tears"), or have a care provider that can administer the drops.
- •Have no known sensitivity /allergy to the TRS01 or formulation excipients.
- •Using adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol
- •Randomization inclusion criteria as specified per protocol.
排除标准
- •Scheduled to undergo cataract surgery in the non-study eye for the duration of the study.
- •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 medium dose
Experimental
干预措施: TRS01 eye drops (Drug)
TRS01 high dose
Experimental
干预措施: TRS01 eye drops (Drug)
Placebo
Placebo Comparator
干预措施: Placebo eye drops (Drug)
结局指标
主要结局
Assessment of Both Systemic and Ocular Adverse Events
时间窗: 14 days
Number of adverse events that occurred during the study
次要结局
未报告次要终点
研究者
研究点 (5)
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