Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 781
- 主要终点
- Ocular Surface Disease Index (OSDI) Total Score at Baseline
研究概览
简要总结
This study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other non-prescription treatments in patients with dry eye disease. Patient and physician assessments completed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of dry eye disease
- •Currently using artificial tears daily
- •Male or female of legal age of consent
- •Normal lid position and closure
- •Exclusion Criteria
- •Patients currently using cyclosporine ophthalmic emulsion 0.05%
- •Participation in other investigational drug or device study
- •Any current or previous topical ophthalmic or oral cyclosporine use within the last three years
排除标准
- 未提供
研究组 & 干预措施
1
- cyclosporine ophthalmic emulsion 0.05%
- artificial tears
干预措施: cyclosporine ophthalmic emulsion 0.05%, artificial tears (Drug)
结局指标
主要结局
Ocular Surface Disease Index (OSDI) Total Score at Baseline
时间窗: Baseline
The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).
次要结局
未报告次要终点