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临床试验/NCT03861728
NCT03861728终止不适用

Avenova for the Treatment of Viral Conjunctivitis

University of Miami2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2018年11月14日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
11
试验地点
2
主要终点
Number of Participants With Clinical Resolution of Viral Conjunctivitis

研究概览

简要总结

The objective of this study is to determine the efficacy Avenova® (0.01% hypochlorous acid) in the treatment of viral conjunctivitis. The investigators hypothesize that patients treated with Avenova® will have a quicker resolution of their ocular signs and symptoms of Viral Conjunctivitis compared with artificial tears.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

A second investigator will randomize the patient to Treatment vs Placebo on initial visit. This "second investigator" will not be involved in screening or follow-up patient visits. At the end of the study the patient arms will be unmasked.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients presenting to the Bascom Palmer Eye Institute
  • Clinical diagnosis of viral conjunctivitis
  • Symptoms less than 1 week duration

排除标准

  • history of allergic conjunctivitis
  • history of herpetic eye disease
  • concurrent diagnosis of bacterial conjunctivitis (based off microbiology plating)
  • Immunocompromised / Immunosuppressed patients
  • Patients with HIV
  • pregnant women
  • prisoners
  • adults who are unable to provide consent

结局指标

主要结局

Number of Participants With Clinical Resolution of Viral Conjunctivitis

时间窗: Up to 8 days

This is the number of participants who on day 7 (+/-1 days) had on clinical examination a 0 or 1 on the follicular conjunctivitis scale and 0 or 1 on the conjunctival injection scale.

次要结局

  • Number of Participants With Symptomatic Resolution of Viral Conjunctivitis(Up to 8 days)
  • Number of Participants With Undetectable Adenoviral DNA(Up to 8 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wendy Lee

Associate Professor

University of Miami

研究点 (2)

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