A Trial of Topical Dexamethasone Versus Artificial Tears for Treatment of Viral Conjunctivitis
Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
Participant gender:
Summary
Viral conjunctivitis causes redness, tearing, swelling, and irritation of the eyes that
typically lasts from 1 to 3 weeks. Current management of this condition focuses on supportive
care while the viral infection completes its course and resolves. However, many patients
still experience substantial discomfort despite standard treatments, and, given the
disproportionate morbidity and potential economic impact associated with an outbreak of
infective conjunctivitis, a therapeutic agent that reduces clinical symptoms of and minimizes
shedding of infectious virus would be desirable.
Povidone-iodine is an antiseptic extensively used in preparation for general surgery,
ophthalmic purposes, and laboratory disinfection. Dilute povidone-iodine solutions inhibit
numerous viruses, bacteria, fungi, and some other parasites. Low cost, effectiveness, and
lack of microbial resistance make povidone-iodine an appealing drug to treat ocular
infections, especially in developing countries. Previously studies showed that
povidone-iodine is a potential option to reduce contagiousness in cases of adenoviral
infections. Dexamethasone 0.1%/povidone-iodine 0.4% it is a mixture containing a steroid and
antiseptic is promising as a suitable therapeutic agent for the treatment of EKC. A small,
prospective, open-label, single-armed clinical trial of dexamethasone 0.1%/povidone-iodine
0.4% administration in humans with symptoms of acute conjunctivitis who tested positive for
adenoviral antigen was therapeutically successful. In other study, dexamethasone
0.1%/povidone-iodine 0.4% combination markedly lowered the viral concentration and improved
the manifestations of the disease.
So, the favorable human data in combination with in vivo results provide a strong impetus for
a human phase III clinical trial to test the efficacy of this drug in a larger group and also
to evaluate complete safety to properly establish the therapeutic benefit versus adverse
effect for these reasons, the investigators chose to study the efficacy of dexamethasone
0.1%/povidone-iodine 0.4% in treating the symptoms and signs of viral conjunctivitis. The
administration of dexamethasone 0.1%/povidone-iodine 0.4% can be a secure, tolerable and
affective treatment to inflammatory and infective component of acute viral conjunctivitis.