NCT03861728

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2018

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2020

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

December 29, 2021

Completed
Last Updated

December 29, 2021

Status Verified

November 1, 2021

Enrollment Period

1.2 years

First QC Date

December 11, 2018

Results QC Date

November 29, 2021

Last Update Submit

November 29, 2021

Conditions

Viral Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 8 days

Secondary Outcomes (2)

  • Number of Participants With Symptomatic Resolution of Viral Conjunctivitis

    Up to 8 days

  • Number of Participants With Undetectable Adenoviral DNA

    Up to 8 days

Study Arms (2)

Viral Conjunctivitis Treatment

EXPERIMENTAL

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

Device: 0.01% Hypochlorous acid

Viral Conjunctivitis Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

0.01% Hypochlorous acidDEVICE

Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)

Also known as: Avenova
Viral Conjunctivitis Treatment
PlaceboOTHER

Placebo to be used four times a day to the affected eye for 2 weeks

Also known as: Basic Sterile Saline
Viral Conjunctivitis Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Related Publications (2)

  • 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

    BACKGROUND

  • 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.

    PMID: 18677274RESULT

MeSH Terms

Conditions

Conjunctivitis, Viral

Condition Hierarchy (Ancestors)

Eye Infections, ViralEye InfectionsInfectionsVirus DiseasesConjunctivitisConjunctival DiseasesEye Diseases

Limitations and Caveats

Early termination led to small numbers of subjects analyzed

Results Point of Contact

Title
Wendy Lee
Organization
University of Miami
wlee@miami.edu
305-326-6434

Study Officials

  • Wendy Lee, MD

    Bascom Palmer Eye Institute, University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
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.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 11, 2018

First Posted

March 4, 2019

Study Start

November 14, 2018

Primary Completion

February 8, 2020

Study Completion

February 8, 2020

Last Updated

December 29, 2021

Results First Posted

December 29, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)