An Evaluation of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Percentage of patients with resolution of all corneal stromal infiltrate(s) in study eye at Test of Cure (TOC) Visit (Day 10)
研究概览
简要总结
The purpose of the study is to determine whether Moxidex ophthalmic solution is safe and effective in treating marginal corneal infiltrates.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of marginal corneal infiltrates of size equal to or less than 1.5mm in diameter, with mild, moderate or severe bulbar conjunctival injection in at least one eye.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Age related.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Moxidex
Moxifloxacin/dexamethasone phosphate ophthalmic solution, one drop in cul-de-sac and 4 drops on closed lids of study eye(s), four times a day, for seven days
干预措施: Moxifloxacin/dexamethasone phosphate ophthalmic solution (Drug)
Moxifloxacin
Moxifloxacin ophthalmic solution 0.5%, one drop in cul-de-sac and 4 drops on closed lids of study eye(s), four times a day, for seven days
干预措施: Moxifloxacin ophthalmic solution 0.5% (Drug)
Dexamethasone
Dexamethasone phosphate solution, 0.1%, one drop in cul-de-sac and 4 drops on closed lids of study eye(s), four times a day, for seven days
干预措施: Dexamethasone phosphate solution, 0.1% (Drug)
结局指标
主要结局
Percentage of patients with resolution of all corneal stromal infiltrate(s) in study eye at Test of Cure (TOC) Visit (Day 10)
时间窗: Day 10
次要结局
- Percentage of patients with eradication of pre-therapy pathogens from the lid of the study eye at TOC Visit (Day 10)(Day 10)