Clinical trial: Biochemical Factors for a Dry Eyed Population (NCT00522847)

Eligibility criteria:
Inclusion Criteria:

        A person is eligible for inclusion in the study, for the dry eye group or control, if she:

          1. Is Caucasian, and has full legal capacity to volunteer.

          2. Is post-menopausal, with menses ceasing more than 12 months ago.

          3. Has moderate or severe dry eye symptoms based on dry eye questionnaire and half of the
             time wants to use eye drops for dry eye symptoms (dry eye group)

          4. Has read, understood and signed an information consent letter.

          5. Is willing and able to follow instructions and maintain the appointment schedule.

          6. Has clear corneas and no active ocular disease.

          7. Has had an ocular examination in the last two years.

        Exclusion Criteria:

          1. Is on hormone replacement therapy (HRT).

          2. Ceased menses due to autoimmune disorders, mumps, chemotherapy, pelvic irradiation or
             smoking.

          3. Has rheumatoid arthritis, diabetes, Sjogren's syndrome or any other systemic disease
             affecting ocular health.

          4. Is using any systemic or topical medications (other than eye drops for dry eye
             symptoms) that may affect ocular health and neuroendocrine system function.

          5. Has undergone corneal refractive surgery.

          6. Is aphakic.

          7. Has any active ocular disease.

          8. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

          9. Is participating in any other type of clinical or research study.

         10. Is a contact lens wearer.

         11. Has blepharitis.
Female
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 75 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? 0