NCT00611403已完成2 期
Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 137
- 主要终点
- Percentage of Patients With Clinical Success at Month 6
研究概览
简要总结
This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily 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
研究组 & 干预措施
RESTASIS®
Active Comparator
Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
干预措施: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) (Drug)
REFRESH ENDURA®
Active Comparator
Artificial Tears (REFRESH ENDURA®)
干预措施: Artificial Tears REFRESH ENDURA® (Drug)
结局指标
主要结局
Percentage of Patients With Clinical Success at Month 6
时间窗: Month 6
Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) \>= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase.
次要结局
- Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6(Baseline, Month 6)
- Change From Baseline in Goblet Cell Density of the Eyes at Month 6(Baseline, Month 6)
研究者
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