Civamide Nasal Solution for the Treatment of Dry Eye
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/11/2017 |
| Start Date: | May 2014 |
| End Date: | September 2015 |
A Phase II, Open-label, Tolerability and Efficacy Study of Civamide Nasal Solution, 0.01%, in Patients With Dry Eye Syndrome
Keratoconjunctivitis sicca (KCS) or Dry Eye Syndrome is a disease of the surface of the eye,
tear film, and related ocular tissues. Millions of people suffer from one form of the
disease or another and its prevalence increases with age. Dry Eye Syndrome sufferers
experience a broad range of symptoms including discomfort, irritation, burning, itching,
redness, pain, gritty feeling, foreign body sensation, blurred vision and ocular fatigue.
Civamide is a TRPV-1 receptor modulator that causes the initial stimulation of neuropeptide
release and subsequent desensitization to further stimulation of the trigeminovascular
system. This provides a pharmacological rational for intranasal route of administration for
disorders mediated by the trigeminal nerve or involving the cranial nerve. In nine clinical
studies of Civamide Nasal Solution, over 50% of the nearly 300 patients who received
Civamide via intranasal administration experienced lacrimation (tearing). This led to the
hypothesis that Civamide Nasal Solution might be an appropriate treatment for Dry Eye
Syndrome.
tear film, and related ocular tissues. Millions of people suffer from one form of the
disease or another and its prevalence increases with age. Dry Eye Syndrome sufferers
experience a broad range of symptoms including discomfort, irritation, burning, itching,
redness, pain, gritty feeling, foreign body sensation, blurred vision and ocular fatigue.
Civamide is a TRPV-1 receptor modulator that causes the initial stimulation of neuropeptide
release and subsequent desensitization to further stimulation of the trigeminovascular
system. This provides a pharmacological rational for intranasal route of administration for
disorders mediated by the trigeminal nerve or involving the cranial nerve. In nine clinical
studies of Civamide Nasal Solution, over 50% of the nearly 300 patients who received
Civamide via intranasal administration experienced lacrimation (tearing). This led to the
hypothesis that Civamide Nasal Solution might be an appropriate treatment for Dry Eye
Syndrome.
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.
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