Besifloxacin Ophthalmic Suspension in Patients With Bacterial Keratitis: A Prospective, Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Time to microbial sterilization of the infected cornea
研究概览
简要总结
This is a study comparing a new treatment for bacterial keratitis (also known as corneal ulcers) with the current standard of care. It is a randomized trial, and the investigators plan to test whether besifloxacin (a new antibiotic) in comparison to the current standard of treatment, fortified antibiotic drops (cefazolin and tobramycin).
详细描述
Hypothesis: patients with bacterial keratitis treated with besifloxacin ophthalmic suspension will have non inferior clinical outcomes as compared to those treated with fortified antibiotic drops (tobramycin and cefazolin)
Bacterial keratitis is a serious ocular problem that can, if not appropriately treated, lead to corneal scarring, perforation, endophthalmitis, and ultimately blindness. Current accepted treatment by some practitioners at a major academic center (McGill University Department of Ophthalmology) for corneal ulcers involves aggressive therapy with fortified antibiotics1, typically tobramycin (for gram negative coverage) and either vancomycin or cefazolin (for gram positive and/or MRSA coverage).
However, there are a number of problems with this treatment method. Patients must obtain the fortified antibiotics from specific pharmacies who must compound the preparations, increasing cost to the patient and potentially risk of contamination. The regimen typically involves every hour, round the clock dosing for at least the 48 hours, causing significant distress to patients (many of whom are eldery) and their families, as well as compliance issues. Finally, fortified antibiotics are toxic, by retarding the epithelial healing rate, as well as having conjunctival and corneal toxic effects.
The investigators' overall goal is to determine whether besifloxacin (at less frequent dosing than that used with fortified antibiotics) can be used safely and effectively in the treatment of bacterial keratitis. Previous studies have examined its effect on bacterial conjunctivitis, but not to the investigators' knowledge bacterial keratitis. However, as some clinicians are already using besifloxacin in this purpose, the investigators wish to examine the safety and efficacy of this.
If the investigators' study shows that besifloxacin is safe and effective in the treatment of bacterial keratitis, a new treatment option for bacterial keratitis may emerge.
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
- 否
入选标准
- •• Provide signed and dated informed consent form
- •Willing to comply with all study procedures and be available for the duration of the study
- •Male or female, aged 18 or older
- •Clinically diagnosed bacterial keratitis, with any size ulcer > 1mm.
排除标准
- •• Previously treated for current episode of bacterial keratitis with an antibiotic drop
- •Corneal Ulcers <1mm
- •Known allergic reaction to components of the study products
研究组 & 干预措施
Group A: Besifloxacin
Patients presenting with bacterial keratitis. These patients will be treated with besifloxacin ophthalmic suspesnion 0.6%, initially 6x a day and tapered down as the patient's condition improves based on the clinical judgement of the treating physician.
干预措施: Besifloxacin (Drug)
Group B: Fortified Antibiotics
Patients presenting with bacterial keratitis. These patients will be treated initially with fortified cefazolin and vancomycin drops every 1 hour around the clock (24hours) for a minimum of 48 hours, and will subsequently have their dosages tapered gradually by the treating physician as is the standard of care for bacterial keratitis.
干预措施: Tobramycin and Cefazolin (Drug)
结局指标
主要结局
Time to microbial sterilization of the infected cornea
时间窗: 2-14 days
We will take repeat cultures and determine when no more bacteria can be cultured
次要结局
- Time until clinical resolution as determined by physician(4 months)
- Final pinhole corrected visual acuity(4 months)
- Severe adverse events: corneal perforation, endophthalmitis(4 months)
- Time until closure of epithelial defect(2-14 days)
- Final corneal scar size(4 months)
研究者
Jean Deschenes
Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre