Clinical trial: Effect of Single Instillation of Three Different Topical Lubricants on Tear Film Thickness in Patients With Dry Eye Syndrome (NCT03161080)

Eligibility criteria:
Inclusion Criteria

        Patients will be eligible for inclusion if all these criteria are respected:

          1. Age of at least 18 years

          2. Provides written informed consent prior to study-related procedures at the screening
             visit

          3. Is able to understand and willing to comply with the procedures and the actions asked
             of him/her

          4. History of dry eye syndrome for at least 3 months

          5. Reports at least 2 of the following symptoms related to dry eye syndrome: foreign body
             sensation, pain, itching, stinging, epiphora, photophobia or blurred vision

          6. Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 10 mm

          7. OSDI score ≥ 23 points

          8. Normal ophthalmic findings except dry eye syndrome

        Exclusion Criteria

        Patients will be excluded under the following circumstances:

          1. Participation in a clinical trial in the 3 weeks preceding the study

          2. Symptoms of a clinically relevant illness in the 3 weeks before the first study day

          3. Presence or history of a severe medical condition as judged by the clinical
             investigator

          4. Intake of parasympathomimetic or anti-psychotic drugs

          5. Wearing of contact lenses

          6. Glaucoma in the medical history

          7. Treatment with corticosteroids in the 4 weeks preceding the study

          8. Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks
             preceding the study

          9. Ocular infection or clinically significant inflammation not related to dry eye
             syndrome

         10. Ocular surgery in the 3 months preceding the study

         11. Sjögren's syndrome

         12. Stevens-Johnson syndrome

         13. History of allergic conjunctivitis

         14. Pregnancy, planned pregnancy or lactating

         15. Known hypersensitivity to any component of the study medication
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
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? Contradiction