A Single-Center, Randomized, Masked Study Comparing the Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After a Single Topical Instillation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Concentration of besifloxacin, gatifloxacin or moxifloxacin in conjunctival tissue.
研究概览
简要总结
The purpose of this study is to assess the concentration of besifloxacin compared to gatifloxacin and moxifloxacin in human conjunctival tissue, following a single drop of the drug instilled topically into the study eye. Conjunctival biopsies will be performed at specified time points, followed by the use of loteprednol etabonate/tobramycin ophthalmic suspension four times a day for 5 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Investigator)
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
- •Willing to avoid all disallowed medications for the appropriate washout periods.
- •Have a best corrected visual acuity of 0.60 logMAR or better in each eye as measured using an ETDRS chart.
排除标准
- •Have a known allergy and/or sensitivity to the test articles or its components or any therapy associated with the trial.
- •Monocular.
- •Have previously participated in a conjunctival biopsy study.
- •Be currently enrolled in an investigational drug or device study or have uses of an investigational drug or device within 30 days of entry into this study.
- •have a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
研究组 & 干预措施
Besifloxacin
Besifloxacin one drop instilled into study eye.
干预措施: Besifloxacin (Drug)
Gatifloxacin
Gatifloxacin one drop instilled into study eye.
干预措施: Gatifloxacin (Drug)
Moxifloxacin
Moxifloxacin one drop instilled into study eye.
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Concentration of besifloxacin, gatifloxacin or moxifloxacin in conjunctival tissue.
时间窗: Biopsies collected at specified time points from 15 minutes to 24 hours
次要结局
- Visual acuity(Day -14 through Day 6(+/-1))
- Slit Lamp Biomicroscopy(Day -14 through Day 6 (+/-))