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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02472223
Recruitment Status : Completed
First Posted : June 15, 2015
Results First Posted : January 6, 2021
Last Update Posted : January 6, 2021
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 Science
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Reducing Adenoviral Patient Infected Days
Actual Study Start Date : March 23, 2015
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
Active Comparator: Betadine 5%
One time in-office administration (4-5 drops) of Betadine 5% limited to 2 minutes, followed by saline lavage.
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.

Other Name: Povidone Iodine

Placebo Comparator: Artificial Tears
One time in-office administration (4-5 drops) of artificial tears limited to 2 minutes, followed by saline lavage.
Drug: Artificial Tears
One time in-office administration (4-5 drops) of artificial tears limited to 2 minutes, followed by saline lavage.
Other Name: Saline Solution




Primary Outcome Measures :
  1. Percent Change From Peak Viral Load [ Time Frame: 21 days ]
    To compare efficacy of Betadine 5% to artificial tears to change from peak viral load in Adenoviral conjunctivitis


Secondary Outcome Measures :
  1. Participant Reported Bothersomeness of Ocular Symptoms [ Time Frame: 21 days ]
    Participants reported bothersomeness of ocular symptoms on a 10 point scale 0=not at all. 10=very bothersome



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


Locations
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United States, Missouri
Mary Migneco
Saint Louis, Missouri, United States, 63110
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 Science
Investigators
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Study Chair: Mae O Gordon, PhD Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02472223    
Other Study ID Numbers: 201412069
First Posted: June 15, 2015    Key Record Dates
Results First Posted: January 6, 2021
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified patient data will be shared. Request for data access should be sent to Mae Gordon mae@wustl.edu.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: July 2023
Access Criteria: Data Access Request will be reviewed by the Steering Committee.
Keywords provided by Washington University School of Medicine:
"Pink Eye"
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctival Diseases
Eye Diseases
Povidone-Iodine
Povidone
Lubricant Eye Drops
Plasma Substitutes
Blood Substitutes
Anti-Infective Agents, Local
Anti-Infective Agents
Ophthalmic Solutions
Pharmaceutical Solutions