NCT02100787已完成不适用
Evaluation of Tear Osmolarity Over Time With Sustained Use of TheraTears Lubricating Drops
Jenkins Eye Care2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2014年4月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in the Ocular Surface Disease Index (OSDI) score
研究概览
简要总结
The objective of the study is to see if there is a change in tear osmolarity over time when moderate to severe dry eye subjects are treated with TheraTears® lubricating drops.
详细描述
The hypothesis is that the measured tear osmolarity from study participants decrease with sustained use of a over-the-counter artificial tears, TheraTears® lubricating drops, over an eight week period. Participant's dry eye symptoms would also improve with sustained use of TheraTears® lubricating drops.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 21 years of age and has full legal capacity to volunteer;
- •Has read and signed the information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Is diagnosed with dry eye syndrome (in at least one eye), indicated by current ocular examination, prior history (self-reported history of dry eye is acceptable) and current use of treatments for dry eye;
- •Has a minimum osmolarity reading of 316 mosm/kg at the baseline visit in at least one eye.
排除标准
- •Has taken part in another research study within the last 30 days;
- •Planned contact lens wear during the course of the study;
- •Staff at the investigational site or family member of site staff or family member of currently enrolled participant;
- •Any subject that violates the washout period by using eye drops during the 72hrs washout period;
- •Has any known ocular disease including active ocular infection, inflammation or allergy, especially Salzmann's nodular degeneration, symptomatic conjunctivochalasis, and fixation disparity syndrome;
- •Used Restasis (or similar topical medication) within the last 6 months;
- •Has a systemic condition that in the opinion of the investigator may affect the dry eye status of the subject, especially those newly diagnosed, newly prescribed and/or unstable;
- •Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation necessary);
- •Use of medications such as: Systemic Antihistamine (e.g., Allegra®, Benadryl®, Claritin®, Dimetapp®, Unisom®, Zyrtec®, etc.), Isotretinoin (e.g., Accutane®, Roaccutane®, Amnesteem®, Claravis®, Isotroin®, Sotret®) or similar medications;
- •Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- •Has undergone ocular surgery(LASIK, Cataract, etc)within the last year.
结局指标
主要结局
Change in the Ocular Surface Disease Index (OSDI) score
时间窗: Baseline and 8 weeks
The OSDI is a questionnaire that the subject completes to gauge their dry eye symptoms.
Change in tear osmolarity
时间窗: Baseline and 8 weeks
次要结局
- Change in visual acuity(Baseline and 8 weeks)
- Change in Tear Break Up Time(baseline and 8 weeks)
- Change in Phenol Red Thread test(baseline and 8 weeks)
- Change in corneal and conjunctival staining(baseline and 8 weeks)
研究者
研究点 (2)
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