Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 115
- 主要终点
- Number of Pterygium Hyperemia Responders at Week 16
研究概览
简要总结
This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a pterygium in at least one eye that has not been previously removed with surgery
排除标准
- •Uncontrolled systemic disease
- •Active eye disease
- •Current or anticipated use of topical eye medications other than artificial tears.
- •Anticipated wearing of contact lenses
研究组 & 干预措施
cyclosporine ophthalmic emulsion 0.05%
One drop in the study eye (or eyes) administered four times daily (QID)
干预措施: cyclosporine ophthalmic emulsion 0.05% (Drug)
Vehicle
One drop in the study eye (or eyes) administered four times daily (QID)
干预措施: Vehicle (Drug)
结局指标
主要结局
Number of Pterygium Hyperemia Responders at Week 16
时间窗: Week 16
Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia.
Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16
时间窗: Baseline, Week 16
Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening.
次要结局
- Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16(Baseline, Week 16)