Ignite Creation Date:
2024-05-06 @ 2:43 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02116244
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2014-04-14
Brief Title:
Civamide Nasal Solution for the Treatment of Dry Eye
Sponsor:
Winston Laboratories
Organization:
Winston Laboratories
Study Overview
Official Title:
A Phase II Open-label Tolerability and Efficacy Study of Civamide Nasal Solution 001 in Patients With Dry Eye Syndrome
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None