Clinical trial: Evaluation of Therapeutic Effect of Bandage Contact Lenses ( BCL) on Dry Eye Caused by Sjogren's Syndrome (NCT02147509)

Eligibility criteria:
Inclusion Criteria:

          -  Gender: male or female between 18~70 years old without wearing contact lens.

          -  Diagnosis and classification: all patients should have the symptoms and signs of
             severe dry eye (conforming to grade 3 or 4 in DEWS2007). Should have at least two
             positive symptoms such as dryness, foreign body sensation, burning, asthenopia, red
             eye or secretion. Tear film breakup time (TFBUT) shorter than 5 seconds and/or
             Schirmer I less than 5 mm/5 min. Corneal fluorescein staining more than 6 scores and
             (or) more than 3 scores of bulbar conjunctiva lissamine green liquor.

          -  Both eyes of all patients were preliminarily examined, the patients with single eye
             that meets the criterion were also investigated. Objective indicators were
             investigated on each eye. While the ocular surface disease index (OSDI) scores and
             SF-36 results were evaluated on an individual base.

          -  All patients should not participate in other medical tests in the past 2 weeks.

          -  Should either not be treated with other medicine at present, or have been treated with
             other medicine but had paused more than 2 weeks

        Exclusion Criteria:

          -  Pregnant or maternity: exclude the patients who are or will be pregnant or during
             breast feeding.

          -  Other surface diseases: exclude the patients who are suspected or complicated by other
             obvious ocular surface diseases.

          -  Severe systemic diseases: exclude the patients with severe primary diseases in heart,
             brain blood vessel, liver, kidney, hematopoietic system and so on.

          -  Intraocular surgery or trauma: exclude the patients with intraocular surgery or trauma
             during 6 months.

          -  Hormone replacement therapy : exclude post-menopausal women who are treated in hormone
             replacement therapy.

          -  Lacrimal punctum: exclude the patients who have been treated with lacrimal punctum in
             1 month.

          -  Glaucoma or high IOP: exclude the patients who have glaucoma or high intraocular
             pressure (IOP) sores.

          -  Exclude the patients who are sensitive to steroid.

          -  Exclude the patients who can't wear the therapeutic bandage contact lens during the
             clinical study.

          -  Immunosuppressive therapies: exclude the patients who are using systemic steroid or
             immunosuppressive therapies which may influent the results of the evaluation of the
             therapeutic effect.

          -  Excluding the patients who may not be suitable for the clinical examination.
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.
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? Entailment