NCT00349440已完成4 期
Efficacy of Topical Cyclosporine Ophthalmic Emulsion for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy
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
- 93
- 试验地点
- 1
- 主要终点
- Dry Eye Symptoms
研究概览
简要总结
The purpose of this study is to evaluate the effect of topical cyclosporine ophthalmic solution 0.05% (Restasis, Allergan) on the signs and symptoms of dry eye in patients undergoing LASIK or photorefractive keratectomy (PRK).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females > 18 years old
- •Mild-moderate symptoms of dry eye prior to surgery
- •Scheduled to undergo bilateral LASIK or PRK
- •Likely to complete all study visits and able to provide informed consent
排除标准
- •Prior use of topical cyclosporine within the last 1 year
- •Known contraindications to any study medication or ingredients
- •Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
- •Ocular disorders
- •Active ocular diseases or uncontrolled systemic disease
- •Active ocular allergies
研究组 & 干预措施
1
Active Comparator
干预措施: Cyclosporine, Refresh Plus (Drug)
2
Placebo Comparator
干预措施: Cyclosporine, Refresh Plus (Drug)
结局指标
主要结局
Dry Eye Symptoms
时间窗: 1.5 years
次要结局
- Dry eye signs(1.5 yrs)
研究者
研究点 (1)
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