Reducing Adenoviral Patient Infected Days

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. 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.

Conditions

• Conjunctivitis
• Adenoviral Conjunctivitis

Interventions

DRUG

Betadine 5%

One time in-office administration (4-5 drops) of Betadine 5% limited to 2 minutes, followed by saline lavage. Betadine 5% exposure to the ocular surface is limited to 2 minutes in-office administration, followed by saline lavage per labeling instructions.

DRUG

Artificial Tears

One time in-office administration (4-5 drops) of artificial tears limited to 2 minutes, followed by saline lavage.

Sponsors & Collaborators

• University of Alabama at Birmingham

  collaborator OTHER

• Illinois College of Optometry

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• Northeastern State University

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Massachusetts Eye and Ear Infirmary

  collaborator OTHER

• Brooke Army Medical Center

  collaborator FED

• University of California, Berkeley

  collaborator OTHER

• New England College of Optometry

  collaborator OTHER

• Massachusetts College of Pharmacy and Health Science

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Mae O Gordon, PhD · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-23

Primary Completion

2018-06-01

Completion

2018-06-01

Countries

• United States

Study Locations