Changes in Tear Osmolarity Over Time With Sustained Use of TheraTears
Completed · Not applicable
Conditions studied: Dry Eye Syndrome
In brief
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.
Key facts
- Study ID
- NCT02100787
- Run by
- Jenkins Eye Care
- People needed
- 18
- Starts
- 2014-04-10
- Expected to finish
- 2016-06-30
- Last updated by the study team
- 2017-03-03
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Jenkins Eye Care — Honolulu, Hawaii, United States
Full record on ClinicalTrials.gov
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