Multicenter, Randomized, Controlled, Single-Masked, Cross-Over Clinical Trial to Evaluate Dry Eye Symptoms With Application of the Oculeve Intranasal Tear Neurostimulator During Exposure to a Controlled Adverse Environment (CAE®)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 185
- 试验地点
- 6
- 主要终点
- Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS)
研究概览
简要总结
This study evaluates the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally (active) compared with the same device applied extranasally (control) relating to symptoms of dry eye exacerbated by the Controlled Adverse Environment model.
详细描述
Participants will be randomized to a single application sequence, either sequence "A" (intranasal application followed by control application) or sequence "B" (control application followed by intranasal application) using the device. Upon entering the CAE, participants will complete dry eye questionnaires every five minutes and will administer the device either intranasally or extranasally in randomized sequence when a certain level of ocular discomfort has been reached.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Moderate to severe dry eye disease
- •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
- •Implanted metallic or electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
- •Corneal transplant in either or both eyes
- •A woman who is pregnant, nursing an infant, or planning a pregnancy at the Screening Visit
- •Be 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
结局指标
主要结局
Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS)
时间窗: Pre-application to Post-application on Day 0
The participant rated their eye dryness (both eyes simultaneously) at all visits and every 5 minutes during CAE exposure by placing a vertical mark on the 100 mm horizontal line to indicate the level of eye dryness. 0 corresponds to "no dryness" and 100 corresponds to "maximal dryness". A negative change from Baseline indicates improvement. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect.
次要结局
- Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score(Pre-application to Post-application on Day 0)