NCT01079858已完成不适用
Evaluation of FID 114657 in Dry Eye Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- Preference based on subject's relief of dry eye
研究概览
简要总结
The primary objective of this study is to assess the overall Meibomian Gland Dysfunction Subject's preference for a particular product. Dry eye symptom relief will also be evaluated based on clinical evaluation and a set of subject questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •must read and sign the informed consent forms (ICF)
- •must agree to comply with the study requirements.
- •Patients must have a best corrected visual acuity of 0.6 LogMar or better in each eye
- •must report having an ocular examination in the last two years
- •must be using topical ocular dry eye therapy (artificial tears or Restasis® at least 2 times per day.
- •must have been diagnosed with Meibomian Gland Dysfunction / Posterior Blepharitis based on the following criteria: must have dry eye symptoms and Meibomian gland expression grade greater than 1.
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 a history and/or current evidence of active intraocular inflammation in either eye.
- •Patients cannot have punctal plugs that were placed less than or equal to 30 days prior to Visit 1, and they cannot have ocular conditions that, in the opinion of the investigator, preclude the safe administration of the test article.
- •They cannot have started or changed the dose of chronic systemic medication within 7 days prior to visit 1, and must remain on a stable dosing regimen for the duration of the study.
- •Patients cannot have participated in another investigational clinical or research study within 30 days of visit
- •Subjects 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 (excluding subjects enrolled with MGD (posterior blepharitis)); 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
Preference based on subject's relief of dry eye
时间窗: 5 weeks
次要结局
未报告次要终点
研究者
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