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
About this trial
This is an interventional treatment trial for Viral Conjunctivitis
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
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
NCT ID
NCT03861728
First Posted
December 11, 2018
Last Updated
November 29, 2021
Sponsor
University of Miami
Collaborators
NovaBay Pharmaceuticals, Inc.
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
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