Clinical trial: Evaluation of FID 114657 in Sjogren's Syndrome Subjects (NCT01079871)

Eligibility criteria:
Inclusion Criteria:

          -  Patients must be at least 18 years of age, must read and sign the informed consent
             form (ICF), and must agree to comply with the study requirements.

          -  Patients must have a best corrected visual acuity of 0.6 LogMar or better in each eye,
             must report having an ocular examination in the last two years and must be using
             topical ocular dry eye therapy (artificial tears or Restasis) at least 4 times per
             day.

          -  Patients must have been diagnosed with Sjogren's Syndrome (confirmed or consistent
             with the American-European Consensus Criteria 2002).

        Exclusion Criteria:

          -  Patients cannot wear contact lenses within one week prior to visit 1 and cannot wear
             their contact lenses during the study.

          -  Patients cannot have a history of hypersensitivity to any component of FID 114657, and
             cannot have diabetes (Type 1 or 2).

          -  Patients cannot have ocular or intraocular surgery or serious ocular trauma within the
             past 6 months, and cannot have an eyelid abnormality that might affect lid function.

          -  Patients cannot have punctal plugs that were placed less than or equal to 30 days
             prior to Visit 1, and cannot have active infections or inflammations not associated
             with Sjogren's Syndrome.

          -  They cannot have started or changed the dose of chronic systemic medication within 7
             days prior to visit 1, and must remain on a stable dosing regimen for the duration of
             the study.

          -  Patients cannot have participated in another investigational clinical or research
             study within 30 days of visit 1 and are not allowed to participate in any other drug
             or device clinical trial for the duration of this study.

          -  Patients cannot have any findings in the vitreous, retina, macula and choroid that
             show signs of active inflammation and/or any structural change that in the opinion of
             the investigator is considered abnormal or unstable for that participant and/or a
             score of greater than 0 for the optic nerve.

          -  Patients can not have had punctal cauterization within 30 days prior to Visit 1, have
             a history of undergoing prior cataract surgery with complications as a result of the
             cataract surgery.

          -  Participants who have undergone prior cataract surgery without complications must be
             at least six months post-op with a stable refractive error.

          -  Patients cannot have received ocular prescription therapy in the last 30 days
             (Restasis can be used as long as stable for at least 30 days).
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? Entailment