Civamide Nasal Solution for the Treatment of Dry Eye

Dry Eye Clinical Trial

Official title:

A Phase II, Open-label, Tolerability and Efficacy Study of Civamide Nasal Solution, 0.01%, in Patients With Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116244
• Other study ID #: WL-1001-08-02
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2014
• Last updated: February 9, 2017
• Start date: May 2014
• Est. completion date: September 2015

Study information

• Verified date: February 2017
• Source: Winston Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Civamide Nasal Spray

Locations

Country	Name	City	State
United States	Wohl Eye Center	Bloomingdale	Illinois
United States	NorthShore University HealthSystem	Glenview	Illinois
United States	Chicago Cornea Consultants, Ltd.	Hoffman Estates	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Winston Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	OSDI Patient Rating Assessment	Change in the OSDI from the Baseline Period to Week 1, 6, and 12.	Weeks 1, 6, and 12
Other	Investigator Rating Scale	Investigator Rating Scale at Day 7, 42, and 84.	Weeks 1, 6, and 12
Other	Requirement for Eye Lubricants	Requirement for Acute Medication	Weeks 1 to 12
Primary	Schirmer Test	Change in Schirmer Test from the Baseline Period to the last week (Week 12) of the Treatment Period.	12 Weeks
Secondary	Schirmer Test	Change in Schirmer Test from the Baseline Period to the Score of each of weeks 1 and 6	Week 1 and 6