Clinical trial: Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops (NCT00001731)

Eligibility criteria:
Diagnosis of CS with documented symptoms and signs (as required below) despite conventional
        management which may include artificial tears, gels and ointments, sympathomimetic agents
        and parasympathomimetic agents:

        Schirmer (without anesthesia) less than or equal to 8 mm/5 min in at least one eye;
        HOWEVER, if Schirmer (without anesthesia) is zero (0) mm, Schirmer with nasal stimulation
        greater than or equal to 3 mm/ 5 min in the same eye, OR;

        Schirmer (with anesthesia) less than or equal to 10 mm/ 5 min in at least one eye and sum
        of interpalpebral staining greater than or equal to 3+ or corneal staining greater than or
        equal to 1+ in the same eye.

        Able and willing to provide informed consent.

        Willingness and ability to meet followup requirements.

        Female patients of childbearing potential must use reliable forms of contraception during
        the study.

        A negative pregnancy test result in women of childbearing potential.

        Normal lid position and closure.

        The following topical (creams, ointments or patches) or systemic medications are allowed as
        long as the patient has been on a stable dose for at least 90 days before the baseline
        visit: Estrogen-progesterone, or other estrogen derivatives.

        If using concomitant medications, and the patient's condition is stable, the patient must
        agree to remain on a stable dose of his or her concomitant medications throughout the study
        period, or if the patient's condition is not stable, then they must agree not to use
        concomitant medications.

        Review of the instructions for use of concomitant medications during the study, prior to
        the eye examination, and agreement from the patient that they will comply with the
        instructions. A copy of the instructions must be given to the patient prior to enrollment.

        Patient must not have uncontrolled systemic disease (e.g., hypertension, diabetes) or the
        presence of any significant illness (e.g., serious gastrointestinal, renal, hepatic,
        endocrine, pulmonary, cardiac, neurologic disease, cancer, AIDS, or cerebral dysfunction)
        that could, in the judgment of the investigator, interfere with interpretation of the study
        results.

        Patients must not have used ophthalmic topical or systemic cyclosporine in the past 90
        days.

        Patients must not have Schirmer readings less than 3 mm/5 min, without anesthesia, in both
        eyes after stimulation thereby indicating end stage lacrimal gland disease.

        Patient must not have active ocular infection or non-KCS ocular inflammation.

        Patient must not have a history of recurrent herpes keratitis or active disease within the
        last six months.

        Patient must not have corneal disorder or abnormality that effects corneal sensitivity or
        normal spreading of the tear film (except SPK).

        Patient must not have severe blepharitis or obvious inflammation of the lid margin which in
        the judgment of the investigator may interfere with the interpretation of the study
        results.

        No plug placement (laser, cautery, silicone, or collagen implant) within one month prior to
        the screening visit.

        No punctal occlusion performed during the study.

        Patient must not have a history of anterior segment surgery or trauma which could affect
        corneal sensitivity (e.g., cataract surgery or any surgery involving a limbal or corneal
        incision within the last 12 months).

        Patient must not have KCS secondary to the destruction of conjunctival goblet cells as
        occurs with vitamin A deficiency or scarring such as that with cicatricial pemphigoid,
        alkali burns, Stevens-Johnson syndrome, trachoma, or irradiation.

        Patients must not use Saligan or antihistamines more than 3 times a week.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.



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