Clinical trial: Diurnal Variation in Tear Osmolarity (NCT01321424)

Eligibility criteria:
Inclusion Criteria:

          1. Healthy males and females ≥ 18 years old

          2. Negative urine pregnancy results for females of childbearing potential

          3. Able to read and sign an informed consent form and show willingness to comply with the
             study protocol visits and procedures

          4. Has 20/40 BCVA or better in at least one eye

          5. Does not currently wear contact lenses

          6. For Aqueous-Deficiency Group:

               -  Has symptoms of Dry Eye

               -  Schirmer testing ≤ 10 mm

               -  Tear Break Up Time ≤ 8 seconds

               -  Conjunctival staining ≥ 1+

               -  Meibomian gland inspissations ≤ 1+

               -  No lid thickening, lid erythema, or thickened, turbid meibomian gland secretions

          7. For Meibomian Gland Disease Group:

               -  Has symptoms of Dry Eye

               -  Schirmer testing ≥ 10 mm

               -  Tear Break Up Time ≤ 8 seconds

               -  Conjunctival staining ≥ 1+

               -  Meibomian gland inspissations ≥ 2+

          8. For Normal Group:

               -  Has no symptoms of Dry Eye

               -  Schirmer testing > 10 mm

               -  Tear Break Up Time > 8 seconds

               -  No or trace Conjunctival staining

               -  No Meibomian gland inspissations

        Exclusion Criteria:

          1. Any topical medication within the last three months, except for artificial tears

          2. Unable to discontinue use of artificial tears during the course of the day for Visit 2

          3. Any Systemic disease, which in the opinion of the Investigator, may affect ocular
             health or confound study results

          4. Any active ocular disease other than Dry Eye Disease, Meibomian Gland Disease or
             Sjogren's Syndrome, which in the opinion of the Investigator, may affect ocular health
             or confound study results

          5. Clinically significant lid or conjunctival abnormalities, neovascularization, corneal
             scars or corneal opacities

          6. Clinically significant limbal or bulbar injection, or corneal staining not due to DES

          7. Has worn hard or rigid gas permeable contact lenses within 1 year

          8. Has worn soft contact lenses within 1 week

          9. Has had eye surgery or an eye injury within 6 months

         10. Positive urine pregnancy results for females of childbearing potential

         11. Any changes in current medication within 30 days of Visit 2 or anticipated change
             during course of study, which in the opinion of the Investigator may confound study
             results
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


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