Civamide Nasal Solution for the Treatment of Dry Eye

NCT ID: NCT02116244

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-09-30

Brief 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.

Conditions

Dry Eye

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Civamide Nasal Spray

Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily for 12 weeks

Group Type: EXPERIMENTAL

Civamide Nasal Spray

Intervention Type: DRUG

Interventions

Civamide Nasal Spray

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Winston Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott B Phillips, MD

Role: STUDY_DIRECTOR

Winston Laboratories

Locations

Wohl Eye Center

Bloomingdale, Illinois, United States

NorthShore University HealthSystem

Glenview, Illinois, United States

Chicago Cornea Consultants, Ltd.

Hoffman Estates, Illinois, United States

Countries

United States

Other Identifiers

WL-1001-08-02

Identifier Type: -

Identifier Source: org_study_id