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NCT02472223 · ClinicalTrials.gov registry record · NA
Reducing Adenoviral Patient Infected Days
A NA study of Conjunctivitis and Adenoviral Conjunctivitis, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT02472223 is a NA study of Conjunctivitis and Adenoviral Conjunctivitis that has completed, run by Washington University School of Medicine. The registered enrollment target is 28 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02472223, a NA study of Conjunctivitis and Adenoviral Conjunctivitis, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- DRUG Betadine 5%
- DRUG Artificial Tears
Study Locations (1)
Missouri
- Mary Migneco - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2015-03-23 |
| Est. Completion | 2018-06-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02472223
The ClinicalTrials.gov registry entry for NCT02472223 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Conjunctivitis appearing as the primary indexed condition, and to 2 interventions - of which Betadine 5% is the first listed.
NCT02472223 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT02472223 about?
NCT02472223 is a clinical study titled "Reducing Adenoviral Patient Infected Days". 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...
What is the current status of trial NCT02472223?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2015-03-23. Estimated completion is 2018-06-01.
What conditions does trial NCT02472223 study?
This clinical trial studies the following conditions: Conjunctivitis, Adenoviral Conjunctivitis.
What interventions are being tested in trial NCT02472223?
The interventions under investigation include: Betadine 5% (DRUG), Artificial Tears (DRUG).
Who is sponsoring clinical trial NCT02472223?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02472223 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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