A Single-site, Single Masked, Prospective Comparison of Three Fluoroquinolone Topical Therapies (Besifloxacin 0.6% or Gatifloxacin 0.5% or Moxifloxacin 0.5%) in the Treatment of Infectious Corneal Ulcers.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Complete Healing
研究概览
简要总结
This Phase II study will evaluate the safety and efficacy of three fluoroquinolone ophthalmic agents to determine the optimal treatment in patients with infectious corneal ulcers.
详细描述
This is a prospective, single masked, comparative, mono-therapeutic trial evaluating three fluoroquinolone agents that are approved and marketed for the treatment of conjunctivitis. Approximately 120 patients who have corneal ulcers greater than 2 mm but less than 6 mm in size who meet all other inclusion criteria will be enrolled into this study. Patients will be randomized in a 2:1:1 ratio to receive besifloxacin 0.6% ophthalmic suspension, gatifloxacin 0.5% ophthalmic solution, or moxifloxacin 0.5% ophthalmic solution.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be between the ages of 18-90 years of age.
- •Patients must be able to understand the nature of this study, give written informed consent prior to study entry, and comply with study requirements.
- •Patients must have a corneal ulcer greater than 2mm but less than 6mm in size.
- •Patients must have corneal ulcer present in only one eye.
- •Patients must agree not to wear contact lenses while on study.
排除标准
- •Patients with multifocal ulcers.
- •Signs of any other viral or fungal infection.
- •Treatment with antibiotics within 14 days of study entry.
- •Treatment with systemic or topical ocular antiviral agents or systemic or topical steroids or topical ocular nonsteroidal anti-inflammatory drugs (NSAIDS) during the prior 14-day period.
- •Known hypersensitivity or allergy to steroids (Loteprednol etabonate) or to any of the ingredients in the three study drugs (Besifloxacin 0.6% or Gatifloxacin 0.5% or Moxifloxacin 0.5%).
- •Contact lens only with no spectacles available.
- •Ocular surgery (including laser surgery) in either eye within 6 weeks prior to entry into this study.
- •Participation in any investigational study within the past 30 days.
- •Pregnant women, minors, or those not able to consent for themselves.
研究组 & 干预措施
Besivance 0.6% Ophthalmic Suspension
A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.
干预措施: Besivance 0.6% Ophthalmic Suspension (Drug)
Zymaxid 0.5% Ophthalmic Solution
A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
干预措施: Zymaxid 0.5% Ophthalmic Solution (Drug)
Vigamox 0.5% Ophthalmic Solution
A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
干预措施: Vigamox 0.5% Ophthalmic Solution (Drug)
结局指标
主要结局
Complete Healing
时间窗: 29 days
The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29.
次要结局
- Healing Rate(29 days)