Clinical Trial: Reducing Adenoviral Patient Infected Days
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Reducing Adenoviral Patient Infected Days
Brief Summary:
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. F
Detailed Summary:
Aim 1: To determine specificity of AdenoPlus(TM) "point of care" immunoassay strips perform in diagnosing the presence of adenovirus compared to qPCR testing.
Aim 2: To determine what percentage of participants will stay in the study for 21 days, the rate of reduction in clinical signs, patient reported symptoms and adenovirus measured by qPCR.
Aim 3: To examine the relationship between the amount of adenovirus measured in tears by qPCR, clinical signs and patient-reported symptoms.
"Pink eye" (adenovirus conjunctivitis Ad-Cs)is a common ocular condition, with afflicted patients comprising as much as 2% of a general practitioner's practice. Partly due to the ability of adenovirus to remain infectious in the desiccated state for weeks at room temperature, Ad-Cs is more contagious than other forms of conjunctivitis and it can be spread via both ocular or respiratory secretions. Owing to the highly contagious nature of this condition, Ad-Cs outbreaks occur where people congregate: schools, military units, nursing homes, workplaces, community and health-care facilities. With respect to the latter, the nosocomial spread of the condition is a significant public health issue as 17% of 145 cases, 44% of 192 cases and 85% of 132 cases were reported to originate at the place of eye examination. The infection spreads from the first affected eye to the fellow eye in a majority of patients, and secondary transmission of viral conjunctivitis to members of the same household is estimated to occur at a rate of 20%. Outbreaks of Ad-Cs spare no nationality, age, gender or social class and because of the epidemic potential of some adenoviral serotypes, Ad-Cs is a reportable condition in Germany and Japan. A treatment that decreases the duration of the infectious period cou
Sponsor: Washington University School of Medicine
Current Primary Outcome: AdenoPlus(TM) [ Time Frame: Up to 18 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: qPCR [ Time Frame: Up to 18 months ]
Original Secondary Outcome: Same as current
Information By: Washington University School of Medicine
Dates:
Date Received: June 8, 2015
Date Started: March 2015
Date Completion: January 2018
Last Updated: May 10, 2017
Last Verified: May 2017
