Civamide Nasal Solution for the Treatment of Dry Eye

Sponsor

Winston Laboratories (Industry)

Overall Status

Completed

CT.gov ID

NCT02116244

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

10.3

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: Civamide Nasal Spray	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Civamide Nasal Spray Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily for 12 weeks	Drug: Civamide Nasal Spray

Arm

Intervention/Treatment

Experimental: Civamide Nasal Spray

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

Drug: Civamide Nasal Spray

Outcome Measures

Primary Outcome Measures

Schirmer Test [12 Weeks]
Change in Schirmer Test from the Baseline Period to the last week (Week 12) of the Treatment Period.

Secondary Outcome Measures

Schirmer Test [Week 1 and 6]
Change in Schirmer Test from the Baseline Period to the Score of each of weeks 1 and 6

Other Outcome Measures

OSDI Patient Rating Assessment [Weeks 1, 6, and 12]
Change in the OSDI from the Baseline Period to Week 1, 6, and 12.
Investigator Rating Scale [Weeks 1, 6, and 12]
Investigator Rating Scale at Day 7, 42, and 84.
Requirement for Eye Lubricants [Weeks 1 to 12]
Requirement for Acute Medication

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wohl Eye Center	Bloomingdale	Illinois	United States	60108
2	NorthShore University HealthSystem	Glenview	Illinois	United States	60026
3	Chicago Cornea Consultants, Ltd.	Hoffman Estates	Illinois	United States	60169