Viral Conjunctivitis Treatment Study

Avenova for the Treatment of Viral Conjunctivitis

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.

Study Overview

• Status: Terminated
• Conditions: Viral Conjunctivitis
• Intervention / Treatment: Device: 0.01% Hypochlorous acid; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Bascom Palmer Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Viral Conjunctivitis Treatment; 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; Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device); Other Names: Avenova
Placebo Comparator: Viral Conjunctivitis Placebo; 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; Placebo to be used four times a day to the affected eye for 2 weeks; Other Names: Basic Sterile Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"	Up to 8 days
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)	Up to 8 days

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: NovaBay Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Wendy Lee, MD, Bascom Palmer Eye Institute, University of Miami

Publications and helpful links

General Publications

• 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
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2018
• Primary Completion (Actual): February 8, 2020
• Study Completion (Actual): February 8, 2020

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 4, 2019

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; Eye Diseases; Conjunctival Diseases; Eye Infections; Eye Infections, Viral; Conjunctivitis; Conjunctivitis, Viral
• Other Study ID Numbers: 20170064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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