Civamide Nasal Solution for the Treatment of Dry Eye

NCT02116244 | Completed Phase 2

• 1 other identifier: WL-1001-08-02
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Schirmer Test

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

  12 Weeks

Secondary Outcomes (1)

• Schirmer Test

  Week 1 and 6

Other Outcomes (3)

• OSDI Patient Rating Assessment

  Weeks 1, 6, and 12

• Investigator Rating Scale

  Weeks 1, 6, and 12

• Requirement for Eye Lubricants

  Weeks 1 to 12

Study Arms (1)

Civamide Nasal Spray

EXPERIMENTAL

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

Drug: Civamide Nasal Spray

Interventions

Civamide Nasal Spray DRUG

Civamide Nasal Spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Winston Laboratories: lead

Study Sites (3)

Wohl Eye Center

Bloomingdale, Illinois, 60108, United States

Location

NorthShore University HealthSystem

Glenview, Illinois, 60026, United States

Location

Chicago Cornea Consultants, Ltd.

Hoffman Estates, Illinois, 60169, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Scott B Phillips, MD

  Winston Laboratories

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 16, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 10, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)