Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 主要终点
- Change in Tear Osmolarity
研究概览
简要总结
The objective of the study is to demonstrate a change in osmolarity over time when moderate to severe dry eye subjects are treated with TheraTears lubricating drops.
详细描述
Symptomatic dry eye subjects exhibited a significantly higher tear osmolarity than observed in normal subjects, this is thought to relate to the inherent tear film instability of dry eye disease. Lubricating eye drops are frequently prescribed to relieve the symptoms of dry eye.
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
- 性别
- All
- 接受健康志愿者
- 是
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 or a osmolarity reading of at least 308 (in worse eye) and at least an 8 point difference between the two eyes.
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;
- •Restasis use can be included if they have been on it for at least 3 months and are stable.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 systemic anti-histamines, as long as they have been on them continuously for at least 1 month. 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;
- •For purposes of this study, ocular conditions that are typically associated with dry eye status, such as meibomian gland dysfunction, mild (i.e. not considered clinically relevant) blepharitis, corneal and conjunctival staining are not considered an exclusion.
研究组 & 干预措施
TheraTears Lubrication Drop
TheraTears Lubricating Eye Drops to be instilled 1 drop in both eyes 4 times per day over a period of 8 weeks.
干预措施: TheraTears Lubricating Eye Drops (Drug)
结局指标
主要结局
Change in Tear Osmolarity
时间窗: 8 weeks
Osmolarity measures will be evaluated using the eye with the highest osmolarity reading at the washout/baseline visit. These baseline values will be compared to subsequent follow-up visits, to determine change from baseline at each visit as well as cumulative change in osmolarity over time.
次要结局
- Change in Visual Acuity(8 weeks)
- Change in Tear Film Breakup Time(8 Weeks)
- Change in Conjunctiva Staining(8 Weeks)
- Change in Corneal Staining(8 weeks)