Civamide Nasal Solution for the Treatment of Dry Eye
Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
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.