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临床试验/NCT02952079
NCT02952079已完成不适用

Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis

University of the Incarnate Word1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2015年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Ocular irritation symptoms (OSDI Questionnaire score)

研究概览

简要总结

The goal of this study is to compare which treatment - BlephEx or MiBoFlo - will be a better option for patients suffering from dry eye secondary to Meibomian Gland dysfunction.

详细描述

The investigators have previously studied the effect of the BlephEx instrument (debridement of lid debris) in relieving signs and symptoms of blepharitis (Connor CG et al, ARVO 2014). This previous study demonstrated positive results from the BlephEx treatment. Warming the eyelids (e.g., using warm wash cloths) still remains a viable treatment option for this disease. However, patients are often non-compliant with warm compress therapy due to the requirement of performing it at least twice per day. The MiBoflo delivers uniform and consistent amounts of heat to the eyelid. It is suggested that two treatments over 30 days is adequate to relieve signs and symptoms of Meibomian gland dysfunction. This equipment is currently used in optometric practices in this country.

There are no clinical studies comparing BlephEx and MiBoflo as treatment options for blepharitis. Hence, the current study will provide new and useful information on which treatment option may be better for treating blepharitis and Meibomian gland dysfunction. Part of this study will also investigate if a combination of BlephEx and MiBoflo treatments is more beneficial to the patient. The data generated will directly benefit clinical practice and impact several millions of patients who suffer from this Blepharitis and / or Meibomian gland dysfunction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Must have dry eye secondary to Meibomian gland dysfunction (posterior blepharitis)

排除标准

  • •Must not have active ocular surface infections. Must not be currently using steroids or immunosuppression eye drops.

研究组 & 干预措施

BlephEx treatment

Active Comparator

Treatment with the BlephEx instrument (lid margin exfoliation)

干预措施: Blephex (Device)

MiBoFlo treatment

Active Comparator

Treatment with the MiboFlo equipment (heat therapy to eyelids)

干预措施: MiboFlo (Device)

结局指标

主要结局

Ocular irritation symptoms (OSDI Questionnaire score)

时间窗: one month

次要结局

  • Tear break-up(one month)

研究者

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

SRIHARI NARAYANAN

Professor

University of the Incarnate Word

研究点 (1)

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