NCT01198782已完成4 期
Evaluating Safety and Efficacy of FID 112903 Post Discontinuation of Long-term Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- The change from baseline in Total Corneal Staining.
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of FID 112903 given as an immediate treatment replacement in dry eye subjects that discontinue at least 6 months use of RESTASIS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients must be at least 18 years of age
- •Patients must have a best corrected visual acuity of 0.6 LogMar or better in each eye, and must use Restasis BID for at least 6 months.
- •Lastly, patients must have a sodium fluorescein (NaFl) corneal staining sum score of greater than or equal to 3 in the worse eye.
排除标准
- •Patients cannot wear contact lenses during the study and cannot have a history of hypersensitivity to any component of FID
- •Patients cannot have ocular or intraocular surgery or serious ocular trauma within the past 6 months, and cannot have punctal plugs of any type.
- •Patients cannot use any prescription topical medication for other ocular conditions (such as glaucoma, uveitis, etc).
- •Patients cannot use systemic medications that may contribute to dry eye if the dosing regimen has not been stable for at least 30 days prior to Visit
- •Patients cannot have ocular conditions that, in the opinion of the investigator, preclude the safe administration of the test article.
- •Patients cannot have a history and/or current evidence of the following: epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; active ocular rosacea; acute or chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal diseases of the eye.
结局指标
主要结局
The change from baseline in Total Corneal Staining.
时间窗: 4 months
次要结局
未报告次要终点
研究者
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