Prospective, Single-Arm Clinical Trial to Evaluate Acute Dry Eye Symptom Relief Assessed During Exposure to a Controlled Adverse Environment (CAE®) Following a 45 Day Period With Application of TrueTear™
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Eye Dryness Score
研究概览
简要总结
This study characterizes acute dry eye symptom control, assessed during exposure to a Controlled Adverse Environment, following use of the TrueTear for 45 days.
详细描述
Subjects will be instructed to use the TrueTear daily for approximately 45 days with assessments in the Controlled Adverse Environment taking place on Day 0 and Day 45. Upon entering the CAE, participants will complete dry eye symptom questionnaires every five minutes and will administer the device when a certain level of ocular discomfort has been reached.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit
- •Normal lid/lash anatomy, blinking function and closure as determined by the Investigator
- •Literate, able to speak English, and able to complete questionnaires independently
排除标准
- •Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to risk of clinically significant increased bleeding
- •Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
- •Contact lens use within 7 days prior to the Screening Visit or anticipate the use of contact lenses at any time during the study
- •Corneal transplant in either or both eyes
- •Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head
- •A woman who is pregnant, nursing an infant, or planning a pregnancy during the duration of the study
- •Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit
研究组 & 干预措施
TrueTear
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
干预措施: TrueTear (Device)
结局指标
主要结局
Eye Dryness Score
时间窗: Day 45
Eye Dryness Score using a visual analog scale assessed in the Controlled Adverse Environment (CAE). The participant rates their current eye dryness (both eyes simultaneously) by scoring 0 to indicate "no discomfort" and 100 to indicate "maximal discomfort". The assessment line length of the scale will be 100 mm.
次要结局
未报告次要终点