Reducing Adenoviral Patient Infected Days (RAPID)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02472223|
Recruitment Status : Recruiting
First Posted : June 15, 2015
Last Update Posted : February 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Conjunctivitis Adenoviral Conjunctivitis||Drug: Betadine 5% Drug: Artificial Tears||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Reducing Adenoviral Patient Infected Days|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 31, 2019|
Active Comparator: Betadine 5%
One time in-office use (4-5 drops)
Drug: Betadine 5%
One-time, in-office administration of Betadine 5%.
Betadine 5% exposure to the ocular surface is limited to 2 minutes in-office administration, followed by saline lavage per labeling instructions.
Other Name: Povidone Iodine
Placebo Comparator: Artificial Tears
Standard of Care
Drug: Artificial Tears
Standard of care
Other Name: Saline Solution
- AdenoPlus(TM) [ Time Frame: Up to 18 months ]To determine specificity of AdenoPlus(TM) "point of care" immunoassay strips perform in diagnosing the presence of adenovirus compared to qPCR testing.
- qPCR [ Time Frame: Up to 18 months ]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.
- qPCR vs. Patient Reported Symptoms [ Time Frame: Up to 18 months ]To examine the relationship between the amount of adenovirus measured in tears by qPCR, clinical signs and patient-reported symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02472223
|Contact: Mae O Gordon, PhD||(314) firstname.lastname@example.org|
|Contact: Leonard W Haertter, BA||(314) email@example.com|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|Contact: Mary Migneco, OD, FAAO 314-362-6123 firstname.lastname@example.org|
|Contact: May Willett, COT (314) 362-6125 email@example.com|
|Study Chair:||Mae O Gordon, PhD||Washington University School of Medicine|