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临床试验/NCT01478256
NCT01478256已完成4 期

A Comparative Study in the Clinical and Microbial Efficacy of Topical Besifloxocin Ophthalmic Suspension 0.6% With Erythromycin Ophthalmic Ointment 0.5% BID for the Management of Acute Blepharitis

John, George, M.D.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Improvement in Signs and Symptoms of Blepharitis

研究概览

简要总结

This study looks at the improvements in signs and symptoms in patients with inflammation of the lids, blepharitis, using two different FDA approved topical antibiotic agents, Besifloxocin and Erythromycin. It also evaluates the bacterial cultures in these patients for microbiologic evidence of improvement.

详细描述

This is a pilot project involving thirty patients with a specific form of inflammtion of the lids called anterior blepharitis. The patients are graded for their signs a symptoms and then randomized to receive either topical Besifloxocin or Erythromycin in addition to standard lid hygiene measures. All patients have cultures of their eyelids performed prior to initiating therapy and are followed for four weeks. The antibiotics are used for two weeks following which repeat cultures of the lids are obtained. The patients are followed for one additional week to ensure that there is no recurrence of their symptoms once the antibiotics are discontinued.

Only adult patients (age 18-100)and women who are not of child bearing potential are included in this study. Then patients have to have symptoms and signs of the disease, blepharitis. Patient who are on unstable antibiotic or steroid regimens and those who cannot discontinue contact lens use are not included in this study.

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

入选标准

  • Acute blepharitis, age 18-100, Signs and symptoms of blepharitis -

排除标准

  • women of child bearing potential, eye surgery within three months of study, contact lens wear, use of topical or antibacterial agents in past two weeks, use of topical or oral steroids in past two weeks unless stable dosage

研究组 & 干预措施

Besifloxocin

Active Comparator

Use of topical besifloxocin to treat acute blepharitis

干预措施: Besifloxocin (Drug)

Erythromycin

Active Comparator

Topical Erythromycin ointment for treatment of acute blepharitis

干预措施: Erythromycin (Drug)

结局指标

主要结局

Improvement in Signs and Symptoms of Blepharitis

时间窗: Four weeks

Signs and symptoms of blepharitis were scored and determined before and after treatment with two different antibiotics

次要结局

  • Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics(Three weeks)

研究者

发起方
John, George, M.D.
申办方类型
Industry
责任方
Principal Investigator
主要研究者

George John, M.D.

Prinicipal Investigator

John, George, M.D.

研究点 (1)

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