REDUCING ADENOVIRAL PATIENT-INFECTED DAYS (RAPID)

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 DESCRIPTION (provided by applicant): Adenoviral conjunctivitis (Ad-Cs) is a prevalent condition comprising as much as 2% of a general practitioner's practice, is highly contagious, and has considerable economic impact. Because of the epidemic potential of some adenoviral serotypes, Ad-Cs is a reportable condition in Germany and Japan. An estimated $670 million is spent annually on the management of acute conjunctivitis, and afflicted patients miss on average five days of work or school (range 2-10). A treatment that reduces patient symptoms or contagion by even two or three days would have significant public health and economic impact. There are no FDA-approved treatments for Ad-Cs. The ideal treatment for Ad-Cs would be safe, effective, low- cost and widely accessible. Povidone iodine (PVP-I) meets these criteria. PVP-I has broad- spectrum antimicrobial effectiveness and an excellent safety profile. "Off-label" use of PVP-I to treat Ad-Cs has been promoted by influential editorials and reviews within the optometric and ophthalmological communities. A significant minority of clinicians report using PVP-I to treat Ad- Cs. Unfortunately, studies of PVP-I for the treatment of Ad-Cs have been uncontrolled, unmasked and/or underpowered. The urgency for a definitive study has increased with the growing off-label use of PVP-I to treat Ad-Cs. Results from a definitive study will affect clinical practice whether PVP-I is found effective or not. Absence of effect would spare hundreds of thousands from ineffective treatment. Either result would provide a rational basis for deciding whether such treatment should be covered in health insurance plans. Our long-term goal is to conduct a definitive, randomized clinical trial that evaluates whether or not a single, in-office application of 5% PVP-I is more effective than standard care with artificial tears at reducing vira load and improving symptoms in patients with Ad-Cs. The specific aims of this planning study "Reducing Adenoviral Patient-Infected Days" (RAPID) is to provide key planning parameters for a national, multi-site clinical trial to test this hypothesis definitively.