Civamide Nasal Solution for the Treatment of Dry Eye

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.