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Civamide Nasal Solution for the Treatment of Dry Eye

Primary Purpose

Dry Eye

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Civamide Nasal Spray

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Dry Eye, Civamide, Zucapsaicin, Neuropeptides, TRPV-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Wohl Eye Center
NorthShore University HealthSystem
Chicago Cornea Consultants, Ltd.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Civamide Nasal Spray

Arm Description

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

Outcomes

Primary Outcome Measures

Schirmer Test

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

Secondary Outcome Measures

Schirmer Test

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

Full Information

NCT ID

NCT02116244

First Posted

April 14, 2014

Last Updated

February 9, 2017

Sponsor

Winston Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT02116244

Brief Title

Civamide Nasal Solution for the Treatment of Dry Eye

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Winston Laboratories

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

Keywords

Dry Eye, Civamide, Zucapsaicin, Neuropeptides, TRPV-1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Civamide Nasal Spray

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Civamide Nasal Spray

Primary Outcome Measure Information:

Title

Schirmer Test

Description

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

Time Frame

12 Weeks

Secondary Outcome Measure Information:

Title

Schirmer Test

Description

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

Time Frame

Week 1 and 6

Other Pre-specified Outcome Measures:

Title

OSDI Patient Rating Assessment

Description

Change in the OSDI from the Baseline Period to Week 1, 6, and 12.

Time Frame

Weeks 1, 6, and 12

Title

Investigator Rating Scale

Description

Investigator Rating Scale at Day 7, 42, and 84.

Time Frame

Weeks 1, 6, and 12

Title

Requirement for Eye Lubricants

Description

Requirement for Acute Medication

Time Frame

Weeks 1 to 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott B Phillips, MD

Organizational Affiliation

Winston Laboratories

Official's Role

Study Director

Facility Information:

Facility Name

Wohl Eye Center

City

Bloomingdale

State/Province

Illinois

ZIP/Postal Code

60108

Country

United States

Facility Name

NorthShore University HealthSystem

City

Glenview

State/Province

Illinois

ZIP/Postal Code

60026

Country

United States

Facility Name

Chicago Cornea Consultants, Ltd.

City

Hoffman Estates

State/Province

Illinois

ZIP/Postal Code

60169

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Civamide Nasal Solution for the Treatment of Dry Eye

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