Civamide Nasal Solution for the Treatment of Dry Eye

Inclusion criteria

• Patients must be aged 18 years or older.
• Patients must have documented moderate to severe evaporative Dry Eye Syndrome for at least 6 months.
• Patients must have a Schirmer (with anesthesia) of ≤ 8 per 5 minutes in at least one eye at Screening and Baseline (Day 1).
• 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).
• Patients must have normal lid position and closure.
• 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.
• Informed consent must be provided.

Exclusion criteria

• Patients with severe inflammatory Dry Eye Syndrome.
• Patients with Dry Eye Syndrome secondary to Sjögren's Syndrome.
• Patients with Schirmer (with anesthesia) of >8 per 5 minutes in both eyes.
• Patients who are allergic to Civamide or any similar products, or excipients of Civamide Nasal Solution 0.01%.
• Patients with history of previous ocular surgery or trauma.
• Patients who require concurrent ocular medication for any eye disorder.
• 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.
• Patients who are receiving or have received within 30 days any experimental systemic medication.