Clinical trial: Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops (NCT02758327)

Eligibility criteria:
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 or a osmolarity reading of at least 308 (in worse eye) and at least an 8 point
             difference between the two eyes.

        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. 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;

          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 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;

         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;

               -  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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers



Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? 0