What is the purpose of this study?
We invite you to participate in this research study because you have had “pink eye” for 4 days or less and are 18 years of age or older.
The purpose of this study is to improve the treatment of “pink eye”. Currently there is no U.S. Food and Drug Administration (FDA) approved treatment for “pink eye”. Standard care recommended by the American Academy of Optometry and American Ophthalmology Academy is with artificial tears to relieve symptoms and to possibly reduce adenovirus in the eye. Another possible treatment is with Betadine 5%, an antiseptic ophthalmic solution used for over 50 years to prepare patient’s eye and surrounding area for eye surgery and to clean minor wounds. Because Betadine 5% kills bacteria and viruses, it may be useful in treating adenoviral conjunctivitis. This study will be among the first to test Betadine 5% for “pink eye”.
What will happen during this study?
In order to determine if you are eligible for this investigational treatment you will need to do the following as part of the screening process:
- Complete questionnaires about symptoms of pink eye, lost days of work or school and transmission of “pink eye”. You are free to skip questions that you would prefer not to answer.
- Receive a comprehensive eye examination. Give a sample of tears to confirm “pink eye” by genetic diagnosis and immunoassay.
- Ask a few questions about your past health history such as any allergies, problems with your thyroid and past eye conditions.
- We will conduct a urine pregnancy test if you are a woman that is capable of becoming pregnant.
Treatment
If after completing the screening process you are eligible to continue in the study, you will receive treatment that day. Steps in treatment are:
- First, you will receive a drop of a topical anesthetic (numbing drop) in the infected eye.
- 50% of the patients will receive a one-time, in-office dose of artificial tears and 50% of the patients will receive Betadine 5%.
- After approximately 2 minutes, the treatment will be flushed out of the eye with a sterile eye wash.
This will be a double-blind study. This means neither you nor your doctors conducting your follow up care will know whether you received Betadine 5% or not. If medically necessary, the doctor can find out whether you received artificial tears or Betadine 5%. Participants will be instructed to use one drop of artificial tears four times a day in the infected eye as long as symptoms persist.
Follow-Up Visits
It is important to know at what point in time you become free of pink eye symptoms and free of adenovirus. For this reason, your pink eye symptoms and adenovirus levels will be measured at each visit at day(s) 1, 4, 7, 14 and 21 after today. Each follow up visit is about 30 minutes and you will be asked to:
- Complete a questionnaire about symptoms of pink eye, lost days of work or school and transmission of “pink eye.” You are free to skip questions that you would prefer not to answer.
- Receive a comprehensive eye examination.
- Give a sample of tears to measure adenovirus levels.
- Receive a $20 Gift Card for each follow-up visit.