A Single Center, Randomized, Controlled, Single-Masked, Cross-Over Clinical Pilot Study to Evaluate the Reduction in the Exacerbation of the Symptoms of Dry Eye Upon Exposure to a Controlled Adverse Environment (CAESM) With Treatment by the Oculeve Nasal Lacrimal TENS Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score
研究概览
简要总结
The purpose of this study was to evaluate the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally compared with the same device applied extranasally (control) in treating the symptoms of dry eye exacerbated by the Controlled Adverse Environment (CAE) Model.
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
- •Bilateral dry eyes
- •Capable of providing written informed consent
排除标准
- •Chronic or recurring epistaxis (nosebleeds)
- •Uncontrolled systemic disease
- •Blood coagulation disorder
- •Females who are pregnant, nursing or planning a pregnancy
结局指标
主要结局
Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score
时间窗: Pre-application to Post-application on Day 0
The participant graded their eye discomfort prior to CAE entry, during CAE exposure to threshold, then starting 1 minute after treatment application every 5 minutes in each eye separately using the Ora Calibra ODS where: 0=no discomfort to 4=constant discomfort. Data from the analysis eye was used to determine effectiveness. The analysis eye was defined as the first eye that reached the threshold and resulted in the device application. If both eyes reached the threshold at the same time point, the analysis eye was the eye with the lowest baseline Schirmer test score (a test to determine if the eye produces enough tears to keep it moist; \>10 mm is normal) or, if the Schirmer test scores were equal, the right eye. A negative change from Baseline indicates improvement.
次要结局
- Change From Pre-Application to Post-Application in Dry Eye Symptoms (DES) Using a Visual Analog Scale (VAS)(Pre-application to Post-application on Day 0)
