NCT01368198已完成不适用
The Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Measurement of the tear film break-up time using DET sodium fluorescein strips.
研究概览
简要总结
The primary objective of this investigation will be to quantify the increase in tear film break-up time (TFBUT) associated with the instillation of a single eyedrop of an Ocular Emulsion in dry eye sufferers.
详细描述
The secondary objective of this investigation will be to compare the tear film break up time measured with two different techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must be 18 years of age or older;
- •The subject must have a best corrected visual acuity of 0.6 LogMAR (~6/24) or better in each eye
- •The subject must not have used any topical ocular drops for approximately 24 hours prior to the enrolment/screening visit
- •The subject must be classified as dry eye at enrolment/screening visit according to the following criteria:
- •Subjects' self-assessment of dry eye status (answer of at least "some of the time" to the question, "How often have your eyes felt dry enough to want to use eye drops?");
- •TFBUT measured with DET ≤ 5 seconds in at least one eye;
- •Grade 1 for meibomian gland expression in both eyes;
- •Evidence of missing meibomian glands in both eyes.
排除标准
- •History or evidence of ocular or intraocular surgery in either eye within the past six months.
- •History or evidence of serious ocular trauma in either eye within the past six months.
- •Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
- •History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
- •Use of any concomitant topical ocular medications during the study period.
- •Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation.
- •Participation in an investigational drug or device study within 30 days of entering this study.
结局指标
主要结局
Measurement of the tear film break-up time using DET sodium fluorescein strips.
时间窗: Enrollment Test visit 1
次要结局
- Measurement of the tear film break-up time in a non invasive manner using the Tearscope®. Measurement of the tear film break-up time in a non invasive manner using the Tearscope®.(Enrollment Test visit 2)
研究者
研究点 (4)
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