NCT01296542已完成4 期
A Comparison of Prophylactic Antibacterial Efficacy of Besivance Versus VIGAMOX Administered for Three Days and One Hour Prior to Phacoemulsification
Bucci Laser Vision Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年5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
- 60
- 试验地点
- 1
- 主要终点
- Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days
研究概览
简要总结
To compare antibacterial efficacy of Besivance versus VIGAMOX for decreasing bacteria of the conjunctiva and lid margins in cataract patients prior to surgery after both 1 hour and 3 days of treatment.
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
- 是
入选标准
- •Man or woman 18 years of age or older.
- •Physically capable of instilling eye drop or have an appropriate person available to assist in administration of eye drops 4 times a day.
- •Scheduled for phacoemulsification with intraocular lens (IOL) implantation for the treatment of cataract.
- •Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and be medically cleared for surgery.
- •Willing to adhere to the prohibitions and restrictions specified in this protocol.
- •Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
排除标准
- •Known allergy or contraindication to the test article(s) or their components.
- •Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters.
- •Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.
- •History of any significant illness that could be expected to interfere with the study parameters. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.
- •Use of disallowed therapies (systemic or topical):
- •Fluoroquinolone anti-infective agents (systemic or topical) within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study.
- •Use of contact lenses for one week prior to the study and for the duration of the study.
- •Received an experimental drug or used an experimental medical device within 21 days before the planned start of treatment.
研究组 & 干预措施
VIGAMOX
Active Comparator
Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
干预措施: Moxifloxacin Ophthalmic (Drug)
Besivance
Active Comparator
Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
干预措施: Besifloxacin Ophthalmic (Drug)
结局指标
主要结局
Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days
时间窗: Following 3 days of antibiotic drops topically instilled
Lid and Conjunctival cultures will be taken to measure bacterial colonization.
次要结局
未报告次要终点
研究者
Frank A. Bucci, Jr., M.D.
Principal Investigator
Bucci Laser Vision Institute
研究点 (1)
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