Clinical trial: Assessment of Inflammatory and Functional Changes in the Ocular Surface Associated With Dry Eye Disease (NCT00809003)

Eligibility criteria:
Inclusion Criteria:

        Inclusion criteria (Sjogren's group)

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

          1. Has been diagnosed to have SS(confirmed via American-European Consensus Criteria
             2002)and dry eye and half of the time wants to use eye drops for dry eye symptoms (dry
             eye group).

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

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

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

        Inclusion criteria (severe DE group)

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

          1. 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)

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

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

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

        Inclusion criteria (control group)

        A person is eligible for inclusion in the study, for the control group, if he/she:

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

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

          3. Has clear corneas and no active ocular disease.

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

        Exclusion Criteria:

        A person will be excluded from the study if he/she (Sjogren's group):

          1. Is a contact lens wearer.

          2. Has any clinically significant belpharitis.

          3. Has undergone corneal refractive surgery.

          4. Is aphakic.

          5. Has any active ocular disease.

          6. Is using any systemic or topical medications that may affect ocular health.

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

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

        A person will be excluded from the study if he/she (Dry eye group):

          1. Is a contact lens wearer.

          2. Has any clinically significant belpharitis.

          3. Has undergone corneal refractive surgery.

          4. Is aphakic.

          5. Has any active ocular disease.

          6. Is using any systemic or topical medications that may affect ocular health.

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

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

        A person will be excluded from the study if he/she (control group):

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

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

          3. Has undergone corneal refractive surgery.

          4. Is aphakic.

          5. Has any active ocular disease.

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

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

          8. Is a contact lens wearer.

          9. Has blepharitis.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 17 Years old.
Subject must be at most 70 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? 1