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临床试验/NCT01230593
NCT01230593已完成不适用

A 5-year Multicenter Prospective Randomized Trial Comparing Three Conservative Chalazion Treatments

McMaster University3 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
3
主要终点
Number of Participants With Complete Resolution

研究概览

简要总结

An eyelid stye, or chalazion, is the most common eyelid ailment, and is caused by the blockage of one of the oil secreting glands of the eyelid (meibomian glands). This leads to a typically painful, swollen, and red eyelid bump that lasts from days to weeks and months. The chalazion may cause tearing, pressure on the cornea, and irritation, all of which contribute to its morbidity. There are many anecdotal first line treatments for this condition, including warm compresses to the eyelid, topical antibiotics, topical steroids, topical combination antibiotic/steroid, and oral antibiotics. There have been no clinical trials to compare the efficacy of any of these conservative treatments. We wish to determine the most effective conservative medical treatment for chalazia.

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
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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Hot Compress

Active Comparator

"Hot Compress"

干预措施: Hot Compresses (Other)

Tobrex

Active Comparator

"Hot Compress", "Tobrex Drops", "Tobrex Ointment"

干预措施: Hot Compress plus Tobramycin Drops and Ointment (Drug)

Tobradex

Active Comparator

"Hot Compress", "Tobradex Drops", "Tobradex Ointment"

干预措施: Hot compress plus Tobramycin/Dexamethasone Drops and Ointment (Drug)

结局指标

主要结局

Number of Participants With Complete Resolution

时间窗: 4-6 weeks

Defined as number of patients with chalazion size regression of 100%

次要结局

  • Chalazion Size Difference Post-Treatment(baseline and 4-6 weeks)

研究者

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

Albert Wu

M.D. Ph.D.

McMaster University

研究点 (3)

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