Clinical trial: Civamide Nasal Solution for the Treatment of Dry Eye (NCT02116244)

Eligibility criteria:
Inclusion Criteria:

          1. Patients must be aged 18 years or older.

          2. Patients must have documented moderate to severe evaporative Dry Eye Syndrome for at
             least 6 months.

          3. Patients must have a Schirmer (with anesthesia) of ≤ 8 per 5 minutes in at least one
             eye at Screening and Baseline (Day 1).

          4. Patients must have a calculated overall score on the OSDI of >0.1 with no more than
             three responses of not applicable (N/A) at Screening and Baseline (Day 1).

          5. Patients must have normal lid position and closure.

          6. Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative
             urine pregnancy test is required within 14 days of Day 1.

          7. Informed consent must be provided.

        Exclusion Criteria:

          1. Patients with severe inflammatory Dry Eye Syndrome.

          2. Patients with Dry Eye Syndrome secondary to Sjögren's Syndrome.

          3. Patients with Schirmer (with anesthesia) of >8 per 5 minutes in both eyes.

          4. Patients who are allergic to Civamide or any similar products, or excipients of
             Civamide Nasal Solution 0.01%.

          5. Patients with history of previous ocular surgery or trauma.

          6. Patients who require concurrent ocular medication for any eye disorder.

          7. Patients who have used Restasis®, serum tears, or oral omega 3 supplements during the
             last 30 days or oral cyclosporine during the last 90 days.

          8. Patients who are receiving or have received within 30 days any experimental systemic
             medication.
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? Contradiction