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临床试验/NCT00534391
NCT00534391Unknown3 期

Dose Antibiotic Need in Hordeolum After Incision and Curettage? : A Randomized, Placebo-controlled Trial

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
120
试验地点
1
主要终点
Pain scale

研究概览

简要总结

To compare the effectiveness of combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin) with placebo (artificial tear) in the treatment of hordeolum after incision and curettage

详细描述

Hordeolum is a common eyelid disease. In case of mass, I&C is required but role of antibiotic after I&C is not clear. It may not need in post drainage period.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • at least 5-millimeters hordeolum
  • the onset within 7 days

排除标准

  • previous incision and curettage of the same site within 1 month or more than 3 times
  • lesions in the adjacent areas suggesting of complications associated with hordeolum such as preseptal cellulitis or blepharitis
  • The patients with immunodeficiency, history of bleeding tendency
  • allergy to aminoglycoside, polymyxin B, gramicidin, xylocaine and povidone iodine

研究组 & 干预措施

B

Placebo Comparator

Artificial tear containing antibiotic solution base

干预措施: Artificial tear (Drug)

A

Experimental

combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin)

干预措施: neomycin sulfate, polymyxin B sulfate and gramicidin (Drug)

结局指标

主要结局

Pain scale

时间窗: 1,3,7 days after treatment

次要结局

  • Mass size and duration of cure(1, 3, 7, 30 days after treatment)

研究者

申办方类型
Other

研究点 (1)

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