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Reducing Adenoviral Patient Infected Days (RAPID)

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ClinicalTrials.gov Identifier: NCT02472223
Recruitment Status : Recruiting
First Posted : June 15, 2015
Last Update Posted : May 7, 2018
Sponsor:
Collaborators:
University of Alabama at Birmingham
Illinois College of Optometry
University of Illinois at Chicago
Northeastern State University
Ohio State University
Massachusetts Eye and Ear Infirmary
Brooke Army Medical Center
University of California, Berkeley
New England College of Optometry
Massachusetts College of Pharmacy and Health Sciences
Information provided by (Responsible Party):
Washington University School of Medicine

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. 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Reducing Adenoviral Patient Infected Days
Study Start Date : March 2015
Estimated Primary Completion Date : July 11, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye Tears

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: Patients will be 18 years and older.
  • Duration of pink eye symptoms: No more than 4 days in first affected eye Positive immunoassay test "AdenoPlus(TM)" for presence of adenovirus.
  • Sex: "Pink eye" {adenoviral conjunctivitis (Ad-Cs)} occurs with equal prevalence in males and females, therefore we will recruit both genders.
  • Race/Ethnicity: Individuals of all races and ethnicities will be invited to participate in this study. Patient recruitment will reflect the distribution of race/ethnicity demographics for the patient population specific to each study site.

Exclusion Criteria:

  • Patients with history of herpes simplex infection or corneal ulceration
  • Eye surgery in the last 3 months

Information from the National Library of Medicine

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


Contacts
Contact: Mae O Gordon, PhD (314) 362-3716 gordon.mae@wustl.edu
Contact: Leonard W Haertter, BA (314) 747-1344 haertterl@wustl.edu

Locations
United States, Missouri
Mary Migneco Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Mary Migneco, OD, FAAO    314-362-6123    migneco@vision.wustl.edu   
Contact: May Willett, COT    (314) 362-6125    willetta@vision.wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
University of Alabama at Birmingham
Illinois College of Optometry
University of Illinois at Chicago
Northeastern State University
Ohio State University
Massachusetts Eye and Ear Infirmary
Brooke Army Medical Center
University of California, Berkeley
New England College of Optometry
Massachusetts College of Pharmacy and Health Sciences
Investigators
Study Chair: Mae O Gordon, PhD Washington University School of Medicine

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02472223     History of Changes
Other Study ID Numbers: 201412069
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

Keywords provided by Washington University School of Medicine:
"Pink Eye"

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Inclusion
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
Povidone-Iodine
Lubricant Eye Drops
Anti-Infective Agents, Local
Anti-Infective Agents
Ophthalmic Solutions
Pharmaceutical Solutions