The primary aim of this pilot study is to generate data needed to design a definitive trial
to compare the safety and efficacy of standard care with artificial tears vs. Betadine 5% (5%
povidone-iodine) for the treatment of pink eye due to adenovirus. There is currently no FDA
approved treatment for pink eye, a common and highly contagious eye infection caused by
adenovirus. Standard care as recommended by the American Academy of Ophthalmology and
American Optometric Association is instillation of artificial tears to relieve symptoms and
possibly reduce the virus population. Betadine 5% is a commercially available, broad-spectrum
antiseptic ophthalmic solution used for over 50 years to prepare the patient's eye and
surrounding area for eye surgery. Because Betadine 5% kills bacteria and viruses, it may be
useful in treating adenoviral conjunctivitis. Betadine 5% is inexpensive, safe, widely
available, and immune to the development of bacterial/viral resistance. Betadine 5% has the
potential to significantly impact the clinical management of "pink eye" worldwide.
This pilot study has received funding from the National Eye Institute. Participants who meet
eligibility criteria will be randomized using a masked randomization packet to receive
one-time, in-office treatment with either artificial tears or Betadine 5%.
Patients who agree to study participation will answer questions about their pink eye
symptoms, medical and ocular history, have an eye examination and be tested to confirm "pink
eye" due to adenovirus using a FDA approved "point of care" immunoassay. Participants testing
positive for adenovirus will have a tear sample taken to measure viral load by qPCR.
Randomization and a one-time treatment with either (standard care) artificial tears or
Betadine 5% will be done on the first visit. Follow-up visits are at 1,4,7,14 and 21 days. At
each visit, symptoms of pink eye are asked, a standardized study eye examination is given by
the masked clinician and a sample of tears is taken to assess viral load by qPCR.
Phase:
N/A
Details
Lead Sponsor:
Washington University School of Medicine
Collaborators:
Brooke Army Medical Center Illinois College of Optometry Massachusetts College of Pharmacy and Health Science Massachusetts Eye and Ear Infirmary New England College of Optometry Northeastern State University Ohio State University University of Alabama at Birmingham University of California, Berkeley University of Illinois at Chicago