NCT00704275Unknown4 期
Comparison of Efficacy, Safety and Anti-Inflammatory Effect Between Topical 0.05%Cyclosporine A Emulsion and REFRESH® in Patients With Moderate to Severe Dry Eyes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Corneal and conjunctival staining score
研究概览
简要总结
To compare the efficacy, safety and tolerability of 0.05% topical cyclosporin eye drop to Refresh in moderate to severe dry eye patients. Null hypothesis is: there is no difference between these two groups.
详细描述
Inclusion criteria:
- Participants are moderate to severe dry eye patients aged more than 18 years of age
- Oxford staining scores of more than five.
- OSDI scores of more than 0.1
Outcome measurements:
Main parameter is staining score (corneal + conjunctival) Other parameter is OSDI score, symptom of ocular surface discomfort score, number of daily artificial tear needed, TBUT, Schirmer I score, cytokines level & markers Safety parameters: VA, IOP, cyclosporin level
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate to severe dry eye
排除标准
- •lid anomaly, previous CsA use
研究组 & 干预措施
A
Experimental
0.05% cyclosporin
干预措施: 0.05% cyclosporin eye drop (Drug)
B
Active Comparator
Refresh
干预措施: 0.05% cyclosporin eye drop (Drug)
结局指标
主要结局
Corneal and conjunctival staining score
时间窗: 1 year
次要结局
- Schirmer 1 score(1 year)
研究者
研究点 (1)
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