NCT04945824终止早期 1 期
An Open-label, Multi-center, Bilateral, Human Factors Study to Evaluate the Utilization and Safety of a Novel Intracanalicular Insertion Device in Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Ease of insertion as assessed by Post-Insertion Investigator Questionnaire
研究概览
简要总结
This is an open-label, multi-center, bilateral, human factors study designed to evaluate the utilization and safety of a novel intracanalicular insertion device in healthy subjects and to evaluate the concentration of DEXTENZA in tears. Each subject's participation is expected to last for approximately 1 month from the DEXTENZA insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are a healthy adult subject aged 18 years or older with no known significant health problems
- •Are willing to refrain from wearing contact lens for the duration of the study
- •Are willing and able to comply with clinic visits and study related procedures
- •Are willing and able to sign the informed consent form
排除标准
- •Have known significant health problems
- •Are women of reproductive potential
- •Are breastfeeding
- •Are a known steroid responder
- •Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
- •Have a history of complete punctal occlusion in one or both punctum
- •Currently use topical ophthalmic steroid medications
- •Are unwilling or unable to comply with the study protocol
- •Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular
研究组 & 干预措施
Novel Intracanalicular Insertion Device
Experimental
干预措施: Dexamethasone Ophthalmic (Drug)
Novel Intracanalicular Insertion Device
Experimental
干预措施: Dilator (Device)
结局指标
主要结局
Ease of insertion as assessed by Post-Insertion Investigator Questionnaire
时间窗: Assessed at Visit 1 (Day 1)
次要结局
未报告次要终点
研究者
研究点 (1)
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