Civamide Nasal Solution for the Treatment of Dry Eye

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Civamide Nasal Spray

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Bloomingdale, Illinois, United States, 60108
      • Wohl Eye Center
    • Glenview, Illinois, United States, 60026
      • Northshore University Healthsystem
    • Hoffman Estates, Illinois, United States, 60169
      • Chicago Cornea Consultants, Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schirmer Test	Change in Schirmer Test from the Baseline Period to the last week (Week 12) of the Treatment Period.	12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schirmer Test	Change in Schirmer Test from the Baseline Period to the Score of each of weeks 1 and 6	Week 1 and 6

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Winston Laboratories
• Investigators: Study Director: Scott B Phillips, MD, Winston Laboratories

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 14, 2014
• First Submitted That Met QC Criteria: April 15, 2014
• First Posted (Estimate): April 16, 2014

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Dry Eye; Neuropeptides; Civamide; Zucapsaicin; TRPV-1
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: WL-1001-08-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No