跳至主要内容
临床试验/NCT02313454
NCT02313454已完成不适用

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

Allergan2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2014年11月17日最近更新:
适应症

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

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)

研究者

发起方
Allergan
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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