search
Back to results

Viral Conjunctivitis Treatment Study

Primary Purpose

Viral Conjunctivitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
0.01% Hypochlorous acid
Placebo
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Viral Conjunctivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients presenting to the Bascom Palmer Eye Institute
  • Clinical diagnosis of viral conjunctivitis
  • Symptoms less than 1 week duration

Exclusion Criteria:

  • history of allergic conjunctivitis
  • history of herpetic eye disease
  • concurrent diagnosis of bacterial conjunctivitis (based off microbiology plating)
  • Immunocompromised / Immunosuppressed patients
  • Patients with HIV
  • pregnant women
  • prisoners
  • adults who are unable to provide consent

Sites / Locations

  • University of Miami Bascom Palmer Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Viral Conjunctivitis Treatment

Viral Conjunctivitis Placebo

Arm Description

Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid

Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline

Outcomes

Primary Outcome Measures

Number of Participants With Clinical Resolution of Viral Conjunctivitis
This is the number of participants who on day 7 (+/-1 days) had on clinical examination a 0 or 1 on the follicular conjunctivitis scale and 0 or 1 on the conjunctival injection scale.

Secondary Outcome Measures

Number of Participants With Symptomatic Resolution of Viral Conjunctivitis
This is the number of participants who on day 7 (+/-1 days) answered on clinical questionaire "none" or "mild" to each of the following list of 7 symptoms: "overall symptoms that affect your daily activities", "itching", "tearing", "pain", "feeling that your lids are stuck together in the morning", "sensitivity to light", "blurry vision"
Number of Participants With Undetectable Adenoviral DNA
This is the number of participants who on day 7 (+/-1 days) had undetectable adenoviral DNA by quantitative Polymerase Chain Reaction (qPCR) (Ct > 35)

Full Information

First Posted
December 11, 2018
Last Updated
November 29, 2021
Sponsor
University of Miami
Collaborators
NovaBay Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03861728
Brief Title
Viral Conjunctivitis Treatment Study
Official Title
Avenova for the Treatment of Viral Conjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 Pandemic
Study Start Date
November 14, 2018 (Actual)
Primary Completion Date
February 8, 2020 (Actual)
Study Completion Date
February 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
NovaBay Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to determine the efficacy Avenova® (0.01% hypochlorous acid) in the treatment of viral conjunctivitis. The investigators hypothesize that patients treated with Avenova® will have a quicker resolution of their ocular signs and symptoms of Viral Conjunctivitis compared with artificial tears.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Conjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Masking Description
A second investigator will randomize the patient to Treatment vs Placebo on initial visit. This "second investigator" will not be involved in screening or follow-up patient visits. At the end of the study the patient arms will be unmasked.
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Viral Conjunctivitis Treatment
Arm Type
Experimental
Arm Description
Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid
Arm Title
Viral Conjunctivitis Placebo
Arm Type
Placebo Comparator
Arm Description
Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline
Intervention Type
Device
Intervention Name(s)
0.01% Hypochlorous acid
Other Intervention Name(s)
Avenova
Intervention Description
Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Basic Sterile Saline
Intervention Description
Placebo to be used four times a day to the affected eye for 2 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Clinical Resolution of Viral Conjunctivitis
Description
This is the number of participants who on day 7 (+/-1 days) had on clinical examination a 0 or 1 on the follicular conjunctivitis scale and 0 or 1 on the conjunctival injection scale.
Time Frame
Up to 8 days
Secondary Outcome Measure Information:
Title
Number of Participants With Symptomatic Resolution of Viral Conjunctivitis
Description
This is the number of participants who on day 7 (+/-1 days) answered on clinical questionaire "none" or "mild" to each of the following list of 7 symptoms: "overall symptoms that affect your daily activities", "itching", "tearing", "pain", "feeling that your lids are stuck together in the morning", "sensitivity to light", "blurry vision"
Time Frame
Up to 8 days
Title
Number of Participants With Undetectable Adenoviral DNA
Description
This is the number of participants who on day 7 (+/-1 days) had undetectable adenoviral DNA by quantitative Polymerase Chain Reaction (qPCR) (Ct > 35)
Time Frame
Up to 8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients presenting to the Bascom Palmer Eye Institute Clinical diagnosis of viral conjunctivitis Symptoms less than 1 week duration Exclusion Criteria: history of allergic conjunctivitis history of herpetic eye disease concurrent diagnosis of bacterial conjunctivitis (based off microbiology plating) Immunocompromised / Immunosuppressed patients Patients with HIV pregnant women prisoners adults who are unable to provide consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Lee, MD
Organizational Affiliation
Bascom Palmer Eye Institute, University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Debabov D, Noorbakhsh C, Wang L, et al. Avenova™ with Neutrox™ (pure 0.01% HOCl) compared with OTC product (0.02% HOCl). NovaBay Pharmaceuticals, Inc., Emeryville, California, USA
Results Reference
background
PubMed Identifier
18677274
Citation
Kim HJ, Lee JG, Kang JW, Cho HJ, Kim HS, Byeon HK, Yoon JH. Effects of a low concentration hypochlorous Acid nasal irrigation solution on bacteria, fungi, and virus. Laryngoscope. 2008 Oct;118(10):1862-7. doi: 10.1097/MLG.0b013e31817f4d34.
Results Reference
result

Learn more about this trial

Viral Conjunctivitis Treatment Study

We'll reach out to this number within 24 hrs