Clinical trial NCT02116244: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Keywords: Dry Eye
Civamide
Zucapsaicin
Neuropeptides
TRPV-1
Lead sponsor: Winston Laboratories
Sponsor class: INDUSTRY
First posted: 2014-04-16
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Schirmer Test
timeFrame: 12 Weeks
Secondary outcomes:
measure: Schirmer Test
timeFrame: Week 1 and 6
Other outcomes:
measure: OSDI Patient Rating Assessment
timeFrame: Weeks 1, 6, and 12
measure: Investigator Rating Scale
timeFrame: Weeks 1, 6, and 12
measure: Requirement for Eye Lubricants
timeFrame: Weeks 1 to 12
Locations:
city: Bloomingdale
country: United States
facility: Wohl Eye Center
state: Illinois
city: Glenview
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants, Ltd.
state: Illinois
Study officials:
affiliation: Winston Laboratories
name: Scott B Phillips, MD
role: STUDY_DIRECTOR
References: