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A Randomized, Double-Masked Trial of Topical Dexamethasone 0.1%/Povidone-iodine 0.4% Versus Artificial Tears for Treatment of Viral Conjunctivitis
Sponsor study identifier
interventional
100
1 country
1
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
February 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 13, 2011
Actual (reported)November 29, 2011
Actual (reported)December 2011
Date type not reportedThis date has not been verified as actual or estimated.
December 2012
Actual (reported)February 2013
Actual (reported)Conjunctival injection
Patient´s information. Each of the symptoms was rated by the patient at presentation and at follow-up on a 4 point scale: none (0), mild (1), moderate (2), or severe (3).
Day 5 of symptom
Conjunctival chemosis
Day 10 of symptom
Conjunctival chemosis
Day 30 of symptom
Patients were instructed to put one drop into each symptomatic eye four times daily for 7 days.
Patients were instructed to put one drop into each symptomatic eye four times daily for 7 days.
dexamethasone 0.1%/povidone-iodine 0.4%
artificial tears 1 drop, 4 times per day
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
dexamethasone 0.1%/povidone-iodine 0.4%
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordUniversity of Campinas
Campinas, São Paulo, Brazil
Sambursky RP, Fram N, Cohen EJ. The prevalence of adenoviral conjunctivitis at the Wills Eye Hospital Emergency Room. Optometry. 2007 May;78(5):236-9. doi: 10.1016/j.optm.2006.11.012.
O'Brien TP, Jeng BH, McDonald M, Raizman MB. Acute conjunctivitis: truth and misconceptions. Curr Med Res Opin. 2009 Aug;25(8):1953-61. doi: 10.1185/03007990903038269.
Romanowski EG, Roba LA, Wiley L, Araullo-Cruz T, Gordon YJ. The effects of corticosteroids of adenoviral replication. Arch Ophthalmol. 1996 May;114(5):581-5. doi: 10.1001/archopht.1996.01100130573014.
Rodrigo Pessoa C Lira
University of Campinas
First Submitted
November 13, 2011
First Posted
November 29, 2011
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
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2. Cullom RD Jr, Chang B, eds. The Wills Eye Manual: Office and Emergency Room Diagnosis and Treatment of Eye Diseases, 2nd ed. Philadelphia: J.B. Lippincott, 1994; chap 5.
Study Completion
February 2013
Actual (reported)Last Updated
December 4, 2014
Record last verified: 2014-12
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Source: ClinicalTrials.gov.
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