NCT00739349已完成2 期
A Phase II, Multi-Center, Double-Masked, Randomized Study of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Cationic Emulsions Compared to Vehicle for the Treatment of the Signs and Symptoms of Dry Eye
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
- Santen SAS
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Assess the safety and efficacy of two doses of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Emulsions
研究概览
简要总结
Study is to assess the safety and efficacy of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Cationic Emulsions QD compared to vehicle for the treatment of the signs and symptoms of dry eye after a 3 month treatment period.
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
- •Male and female 18 years and older
- •Diagnosis of dry eye in both eyes
排除标准
- •Contraindications to the use of the study medications
- •Known allergy or sensitivity to the study medications or their components
- •Female currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test
- •Have participated in an investigational drug or device study within 30 days of Visit 1
研究组 & 干预措施
1
Experimental
Cyclosporine 0.05%
干预措施: NOVA22007 ''Cyclosporine'' (Drug)
2
Experimental
Cyclosporine 0.1%
干预措施: NOVA22007 ''Cyclosporine'' (Drug)
3
Placebo Comparator
vehicle/placebo
干预措施: vehicle/placebo (Drug)
结局指标
主要结局
Assess the safety and efficacy of two doses of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Emulsions
时间窗: Approximately 13 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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