Clinical trial: Evaluation of Blink Tears and Systane Concomitant With Restasis for the Treatment of Dry Eye Symptoms (NCT00565669)

Eligibility criteria:
Inclusion Criteria:

          1. Subject must have dry eye.

          2. Age: 18 years and older.

          3. Males or females

          4. Up to grade 3 conjunctival staining.

          5. Score of no more than 4 on the Subjective Evaluation of Symptoms of Dryness (SESOD) at
             screening.

          6. Currently using Restasis to treat dry eye syndrome (at least for 3 months prior to
             enrollment).

          7. Willing and able to comply with scheduled visits and other study procedures.

        Exclusion Criteria:

          1. Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least
             3 months without improvement.

          2. Known contraindications to any study medication or ingredients.

          3. Planned use of contact lenses (unless discontinued use more than 30 days prior to
             randomization.

          4. Contact lens use during the active treatment portion of the trial.

          5. Active ocular allergies.

          6. Ocular surgery within the past 3 months.

          7. Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.

          8. Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are
             actively being treated or disease that is uncontrollable.

          9. Pregnant or nursing mothers and females of childbearing potential not practicing a
             reliable and medically acceptable method of birth control.

         10. Participation in (or current participation) any investigational drug or device trial.

         11. Conjuctival staining grade 4.
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