Study of Cyclosporine in Post-LASIK Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 621
- 主要终点
- Time to Cure
研究概览
简要总结
This study will evaluate the safety and efficacy of Cyclosporine 0.005% and 0.010% eye drops administered twice daily before and following LASIK 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is scheduled for bilateral LASIK surgery
- •Patient is in good general health
- •Eye glasses prescription of -1 to -8
排除标准
- •Significant Dry Eye
- •Presence of eye disease
- •Uncontrolled systemic disease
- •Previous use of RESTASIS®
研究组 & 干预措施
Cyclosporine 0.010% eye drops
Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
干预措施: Cyclosporine 0.010% eye drops (Drug)
Cyclosporine 0.005% eye drops
Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
干预措施: Cyclosporine 0.005% eye drops (Drug)
Placebo (Vehicle for Cyclosporine)
Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
干预措施: Placebo (Vehicle for Cyclosporine) (Drug)
结局指标
主要结局
Time to Cure
时间窗: 6 Months
Time to cure is defined as the number of days after laser in situ keratomileusis (LASIK) surgery that the patient has corneal sensitivity (the capability of the cornea to respond to stimulation) ≥ 50 millimeters in all 9 regions of both eyes after LASIK surgery. A patient is considered cured at the first of 2 consecutive visits meeting these criteria. The Inter-Quartile Range presented is actually the 25th Quantile and the 75th Quantile obtained from the Kaplan-Meier Model.
次要结局
- Time to Worst Outcome Post-LASIK Surgery in Tear Film Assessment(Months 3 to 6)
- Percentage of Patients With Cumulative Poor Vision(Month 3, Month 4, Month 5, Month 6)
- Worst Outcome Post-LASIK Surgery in Reading Speed Assessment(Months 3 to 6)