NCT00330798已完成4 期
A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief of Patients Status Post-Photorefractive Keratectomy: A Double-Masked Randomized Prospective Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Subjective pain
研究概览
简要总结
The purpose of this study is to compare healing times and subjective pain level responses of nepafenac to placebo after photo refractive keratomileusis (PRK) surgery.
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
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years or older with healthy ocular status and pre-operative refractive anisometropia of less than 2.000 diopters between eyes undergoing bilateral PRK surgery.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Those desiring PRK in only one eye, those in need of additional topical eye medications, those with history of drug/alcohol abuse, women breastfeeding or pregnant.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Nevanac
Experimental
One drop, three times daily, in the assigned eye for the first three postoperative days
干预措施: nepafenac 0.1% (Drug)
Acular LS
Placebo Comparator
One drop, three times daily, in the assigned eye for the first three postoperative days
干预措施: ketorolac 0.4% (Other)
结局指标
主要结局
Subjective pain
时间窗: Day 5
次要结局
- Rate of epithelial healing(Time to event)
研究者
研究点 (1)
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