Viral Conjunctivitis | A Trial of Topical Dexamethasone Versus Artificial Tears for Treatment of Viral Conjunctivitis
Viral Conjunctivitis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - unilateral or asymmetric conjunctivitis, - follicles on the inferior tarsal conjunctiva, - preauricular lymphadenopathy, - an associated upper respiratory infection or - recent contact with a person with a red eye Exclusion Criteria: - history of seasonal allergic conjunctivitis, - use of ocular medication after the beginning of symptoms, - contact lens wear, - history of herpetic eye disease, - history of ocular surgery, - history of chronic ocular disease other than refractive error, - allergy to iodo, pregnancy, - age less than 18 years, - bleeding disorder, - glaucoma, - significant blepharitis or dry eyes on slit lamp examination, - purulent ocular discharge, - corneal epithelial staining with fluorescein, or - intraocular inflammation
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:dexamethasone 0.1%/povidone-iodine 0.4%dexamethasone 0.1%/povidone-iodine 0.4%
Drug:Artificial Tearsartificial tears 1 drop, 4 times per day
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
dexamethasone 0.1%/povidone-iodine 0.4%Patients were instructed to put one drop into each symptomatic eye four times daily for 7 days.
artificial tearsPatients were instructed to put one drop into each symptomatic eye four times daily for 7 days.
Start Date: December 2011
Completed Date: February 2013
Phase: Phase 3
Primary Outcome: Conjunctival injection
Secondary Outcome: Conjunctival chemosis
Study sponsors, principal investigator, and references
Principal Investigator: Rodrigo Pessoa C Lira
Lead Sponsor: University of Campinas, 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.
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.