Reducing Adenoviral Patient Infected Days

NCT02472223 | Completed Results DMC

• 1 other identifier: 201412069
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Conjunctivitis; Adenoviral Conjunctivitis

Keywords

"Pink Eye"

Outcome Measures

Primary Outcomes (1)

• Percent Change From Peak Viral Load

  To compare efficacy of Betadine 5% to artificial tears to change from peak viral load in Adenoviral conjunctivitis

  21 days

Secondary Outcomes (1)

• Participant Reported Bothersomeness of Ocular Symptoms

  21 days

Study Arms (2)

Betadine 5%

ACTIVE COMPARATOR

One time in-office administration (4-5 drops) of Betadine 5% limited to 2 minutes, followed by saline lavage.

Drug: Betadine 5%

Artificial Tears

PLACEBO COMPARATOR

One time in-office administration (4-5 drops) of artificial tears limited to 2 minutes, followed by saline lavage.

Drug: Artificial Tears

Interventions

Betadine 5% DRUG

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.

Also known as: Povidone Iodine

Betadine 5%

Artificial Tears DRUG

One time in-office administration (4-5 drops) of artificial tears limited to 2 minutes, followed by saline lavage.

Also known as: Saline Solution

Artificial Tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• University of Alabama at Birmingham: collaborator
• Illinois College of Optometry: collaborator
• University of Illinois at Chicago: collaborator
• Northeastern State University: collaborator
• Ohio State University: collaborator
• Massachusetts Eye and Ear Infirmary: collaborator
• Brooke Army Medical Center: collaborator
• University of California, Berkeley: collaborator
• New England College of Optometry: collaborator
• Massachusetts College of Pharmacy and Health Science: collaborator

Study Sites (1)

Mary Migneco

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• Morettin CE, Harthan JS, Huecker JB, Perera CD, Than T, Whiteside M, Johnson SD, Shorter E, Migneco MK, Olson CK, Alferez CS, Camp D, Hartwick ATE, Gordon MO. Correlation of Adenoviral Titers with Severity of Adenoviral Conjunctivitis and Time to Viral Clearance for 21 Days. Optom Vis Sci. 2023 Mar 1;100(3):187-193. doi: 10.1097/OPX.0000000000001999. Epub 2023 Feb 7.

  PMID: 36749104 DERIVED

• Whiteside MM, Shorter ES, Margolis MS, Alvi F, Huecker JB, Than TP, Migneco MK, Harthan JS, Morettin CE, Hartwick ATE, Johnson SD, Perera CD, Gordon MO. Success of Masking 5% Povidone-Iodine Treatment: The Reducing Adenoviral Patient Infected Days Study. Optom Vis Sci. 2021 May 1;98(5):469-475. doi: 10.1097/OPX.0000000000001691.

  PMID: 33973917 DERIVED

MeSH Terms

Conditions

Conjunctivitis

Interventions

Povidone-Iodine; Lubricant Eye Drops; Saline Solution

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals; Crystalloid Solutions; Isotonic Solutions

Limitations and Caveats

Small pilot study. Sample consisting of only adults. Lost to follow-up. High false positive rate of point-of-care immunoassay which necessitated a modified intention-to-treat analysis of participants with PCR confirmed Ad-Cs.

Results Point of Contact

• Title: Mae Gordon
• Organization: Washington University School of Medicine

gordon.mae@wustl.edu

3143623716

Study Officials

• Mae O Gordon, PhD

  Washington University School of Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 15, 2015
• Study Start: March 23, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: January 6, 2021
• Results First Posted: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: July 2023
• Access Criteria: Data Access Request will be reviewed by the Steering Committee.

Locations

US (1)