Clinical trial: Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes (NCT00796926)

Eligibility criteria:
Inclusion Criteria:

          1. Subject age is between 40 and 65 years old.

          2. Corneal fluorescein staining present in at least one/five sectors of at least one
             cornea

          3. At least one question out of 6 questions on dry eye symptom present often or all the
             time.

             based on the Salisbury Eye study by Oliver Schein et al. (Does your eye feel dry,
             gritty, red, watery, crusted, stuck in the morning?) Please see appendix 1.

          4. At least one of the following: TBUT <= 5 s or Schirmer I less than 8 mm in at least
             one eye

          5. Yamaguchi score 2 in at least one sector of one of 4 lids (slight advancement of
             Marx's line in line with Meibomian orifice)

          6. Not using non-lubricant ophthalmic drops within the last 30 days and able to abstain
             from non-trial topical eye medications for 6 weeks.

          7. Use of lubricants during the week before recruitment (ranging from 3 times in the week
             to less than 6 times a day every day).

          8. Able to use saline eyedrops during the 7 day 'washout' evaluative phase, between 3
             times over week to less than 6 times a day in all days.

        Exclusion Criteria:

          1. Known history of thyroid disorders (diagnosed by physician).

          2. Known history of Sjogren syndrome or rheumatoid arthritis (diagnosed by physician).

          3. No ocular surgery within 6 months and LASIK within 1 year.

          4. Any intake of central nervous system and hormonal drugs within last 30 days and
             inability to withhold such drugs for at least 6 weeks.

          5. Ocular surface diseases such as pterygium, or obvious lid/orbital disease with
             lagophthalmos.

          6. Anticipated necessity to wear contact lens in the duration of the study.

          7. Not living in the same household as another participant of the study.

          8. Any other specified reason as determined by clinical investigator.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 65 Years

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