A Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Besifloxacin ophthalmic suspension 0.6% Vs Moxifloxacin ophthalmic solution 0.5% in patients with Bacterial conjunctivitis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- The primary outcome measures will be slit lamp biomicroscopy, tear culture examination, ophthalmoscopic examination, redness of the eyes, eye pain, blurred vision, sensitivity to light, burning or itching of the eye, a scratchy feeling in the eye and discharge.
研究概览
简要总结
This study is a comparative, randomized, double blind, multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Besifloxacin ophthalmic suspension 0.6% Vs Moxifloxacin ophthalmic solution 0.5% (Reference Drug) in 200 patients with Bacterial conjunctivitis in india. Date of first enrollment will be 27 April 2010. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The primary outcome measures will be slit lamp biomicroscopy, tear culture examination, ophthalmoscopic examination, redness of the eyes, eye pain, blurred vision, sensitivity to light, burning or itching of the eye, a scratchy feeling in the eye and discharge at day 0 and 5. Secondary outcome will be safety and tolerability and global assessment at day 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
- •Patients providing written informed consent to participate in the trial.
排除标准
- •Patients < 18 & > 60 years.
- •Pregnant or nursing females
- •Known hypersensitivity to fluroquinolones or to any of the study ingredients.
- •Use of any antibiotic within 72 hours of treatment.
- •Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.
- •Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.
结局指标
主要结局
The primary outcome measures will be slit lamp biomicroscopy, tear culture examination, ophthalmoscopic examination, redness of the eyes, eye pain, blurred vision, sensitivity to light, burning or itching of the eye, a scratchy feeling in the eye and discharge.
时间窗: Day 0 and Day 5.
次要结局
- Safety and tolerability(Day 5)
- Global assessment(Day 5)