An Evaluation of the Safety and Efficacy of the Administration of a Fixed Combination of Moxifloxacin 0.5% and Dexamethasone 0.1% Eye Drops Compared With the Individual Administration of Moxifloxacin 0.5% and Dexamethasone 0.1% in the Treatment of Bacterial Ocular Inflammation and Infection (Blepharitis and/or Keratitis and/or Conjunctivitis)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluation of ocular sign/symptoms (hyperemia on bulbar conjunctiva, palpebral conjunctiva, conjunctival exsudates, palpebral erythema at final visit (Day 8)
研究概览
简要总结
Safety and efficacy of antibiotic steroid combination compared with individual administration in the treatment of bacterial ocular inflammation and infection (blepharitis and/or keratitis and/or conjunctivitis).
详细描述
Antibiotic/steroid combination compared to individuals components 8 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of blepharitis and/or keratitis and/or bacterial conjunctivitis
排除标准
- •Uncontrolled glaucoma or intraocular hypertension
- •Wear contact lens during the study
- •Patients with sight in a single eye
- •Suspicious of viral, fungic infection
- •Use of any other ophthalmic drugs during the study
- •Use of immunosuppressant therapy
- •Known or suspected allergy or hypersensibility to any component of study medication
研究组 & 干预措施
2
antibiotic /steroid combination compared with individual administration of steroid and antibiotic
干预措施: Moxifloxacin (Drug)
2
antibiotic /steroid combination compared with individual administration of steroid and antibiotic
干预措施: Dexamethasone (Drug)
1
combination antibiotic steroid compared with individual administration of steroid and antibiotic - new therapeutic indication
干预措施: Moxifloxacin and Dexamethasone combined (Drug)
结局指标
主要结局
Evaluation of ocular sign/symptoms (hyperemia on bulbar conjunctiva, palpebral conjunctiva, conjunctival exsudates, palpebral erythema at final visit (Day 8)
时间窗: Day 8
次要结局
- Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis(Day 8)