An Evaluation of the Prophylactic Efficacy and Safety of the Administration of the Combination Formulation of Moxifloxacin 0.5% and Dexamethasone 0.1% Eye Drops in Inflammation and Infection Post-cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The Percentage of Patients With a Score of Zero for Anterior Chamber Cells.
研究概览
简要总结
To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is effective and safe for the prevention of postoperative inflammation as a consequence of cataract extraction surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •≧18 years of age
- •able to sign an informed consent and complete all required visits
- •intends to have a cataract extraction surgery followed by implantation of a posterior chamber Intraocular lens (IOL)
- •Intraocular Pressure (IOP) ≦ 20 millimeters mercury (mmHg)
排除标准
- •Uncontrolled glaucoma or IOP
- •use of ocular anti-infectious during the study and within 30 days prior to the enrollment, secondary implantation or replacement of IOL in the study eye
- •use of steroid during the study or within 14 days prior to enrollment
研究组 & 干预措施
Vigadexa eye drops
Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
干预措施: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops (Drug)
结局指标
主要结局
The Percentage of Patients With a Score of Zero for Anterior Chamber Cells.
时间窗: Day 15 after cataract surgery
The percentage of patients with a score of zero for Anterior chamber cells. Anterior chamber inflammation was evaluated based on the number of cells per high-power field measured using the narrowest slit beam of the lamp (0.5 at a height of 8mm). Anterior chamber cells was recorded on a 0-4 point scale,0 = Less than 5 cells; 1 = Mild: 5-10 cells; 2 = Moderate:11-20 cells; 3 = Marked: 21-50 cells; 4 = Severe: Greater than 50 cells / hypopyon
The Percentage of Patients With no Ocular Pain
时间窗: Day 15 after cataract surgery
次要结局
未报告次要终点