A Prospective Early-Feasibility Study to Evaluate the Safety and Effectiveness of ETX-4143 2.0 Device in Subjects With Eye Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 8
- 主要终点
- Reduction of eye pain
研究概览
简要总结
A prospective early-feasibility study to evaluate the safety and effectiveness of the ETX-4143 2.0 device. The device is intended to treat subjects with eye pain
详细描述
A prospective early-feasibility study to evaluate the safety and effectiveness of the ETX-4143 2.0 device. The device is intended to treat subjects who suffer from eye pain an do not get relieve from current medications or clinical treatments. Thirty eyes will be enrolled and randomized 2:1 to the investigational treatment or a sham treatment. Improvement in self-reported ocular pain and clinical safety measures will be evaluated.
It is anticipated that the learnings from the study will be used to design future study of the ETX-4143 2.0 device.
All subjects will be followed for 8 weeks. Subjects will only have the worse eye treated if both eyes meet the inclusion/exclusion criteria.
A medical monitor will evaluate the safety of the study on a continual basis.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documented history of eye pain with no relief from currently available medications or treatments
- •Willing to forgo participation in any other clinical stud for the duration of this study
- •Demonstrate sufficient cognitive awareness to comply with the examination process
- •Willing and able to comply with the schedule for follow-up visits
- •Willing to participate in the study as evidenced by signing an informed consent document
排除标准
- •Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study time period, including the follow-up period
- •Any active ocular infection or active ocular inflammation at the time of the screening visit
- •History of herpes keratitis, non-healing corneal epithelial defects, or neurotrophic keratopathy due to corneal herpetic disease, stem cell deficiency, diabetic keratopathy, severe lagophthalmos, or topical anesthetic abuse
- •Any history of significant eye surgery with the prior 90 days
- •Planned eye surgery during the entire study
- •Participation in any clinical study of an investigational product within 30 days prior to enrollment
- •Any history of serious, poorly controlled systemic or ophthalmic condition that could compromise the subject's ability to comply with the protocol or compromise their safety
结局指标
主要结局
Reduction of eye pain
时间窗: Eight weeks
Patient reported level of eye pain
Adverse events
时间窗: Eight weeks
Adverse events related to treatment
次要结局
未报告次要终点