Changes in Tear Osmolarity Over Time With Sustained Use of TheraTears



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:21 - Any
Updated:4/2/2016
Start Date:April 2014
End Date:July 2015
Contact:Loretta T Ng, OD
Email:loritng@gmail.com
Phone:(808) 591-9911

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Evaluation of Tear Osmolarity Over Time With Sustained Use of TheraTears Lubricating Drops

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.

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.

Inclusion Criteria:

1. Is at least 21 years of age and has full legal capacity to volunteer;

2. Has read and signed the information consent letter;

3. Is willing and able to follow instructions and maintain the appointment schedule;

4. 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;

5. Has a minimum osmolarity reading of 316 mosm/kg at the baseline visit in at least one
eye.

Exclusion Criteria:

1. Has taken part in another research study within the last 30 days;

2. Planned contact lens wear during the course of the study;

3. Staff at the investigational site or family member of site staff or family member of
currently enrolled participant;

4. Any subject that violates the washout period by using eye drops during the 72hrs
washout period;

5. Has any known ocular disease including active ocular infection, inflammation or
allergy, especially Salzmann's nodular degeneration, symptomatic conjunctivochalasis,
and fixation disparity syndrome;

6. Used Restasis (or similar topical medication) within the last 6 months;

7. 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;

8. Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal
confirmation necessary);

9. 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;

10. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

11. Has undergone ocular surgery(LASIK, Cataract, etc)within the last year.
We found this trial at
1
site
Honolulu, Hawaii 96814
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Honolulu, HI
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