A Trial of Topical Dexamethasone Versus Artificial Tears for Treatment of Viral Conjunctivitis

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Campinas, Brazil
• Treatments: BB 1101; Cadexomer iodine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Iodine; Lubricant Eye Drops; Povidone; Povidone-Iodine

Criteria

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