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Viral Conjunctivitis Treatment Study

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ClinicalTrials.gov Identifier: NCT03861728
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : April 13, 2021
Sponsor:
Collaborator:
Novabay Pharmaceuticals
Information provided by (Responsible Party):
Wendy Lee, University of Miami

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.

Condition or disease Intervention/treatment Phase
Viral Conjunctivitis Device: 0.01% Hypochlorous acid Other: Placebo Not Applicable

Detailed Description:
Avenova® is a proprietary pure hypochlorous acid under a family of skin cleansing products by NovaBay that has been cleared by the FDA as a 510(k) medical device. Many in vitro studies have evaluated the efficacy of hypochlorous acid against microbacterial and viral agents. In ophthalmology, it is commonly used as a lid cleanser in the treatment of blepharitis and meibomian gland dysfunction. It is applied directly to the lid margin and has an excellent skin and ocular safety profile, which includes a lack of ocular irritation on application.The investigators propose a study to evaluate the role of Avenova® (0.01% hypochlorous acid) in the treatment of common ocular viral infections.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care 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.
Primary Purpose: Treatment
Official Title: Avenova for the Treatment of Viral Conjunctivitis
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

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 Name: 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 Name: Basic Sterile Saline




Primary Outcome Measures :
  1. Clinical resolution of viral conjunctivitis [ Time Frame: 2 weeks ]
    Clinical resolution of viral conjunctivitis as defined by clinical examination. Each visit the patient will be assess by a physician. The patient's visual acuity, intraocular pressure will be checked, and measures of inflammation including corneal surface disease, follicular response of the conjunctiva, scarring of the conjunctiva, and edema of the conjunctiva will be followed on a 0-3 scale. Resolution of viral conjunctivitis will be defined as a 0 or 1 on the follicular conjunctivitis scale with 0 or 1 on the conjunctival injection score. The time to resolution will then be compared.

  2. Symptomatic resolution of viral conjunctivitis [ Time Frame: 2 weeks ]
    Symptomatic resolution of viral conjunctivitis as determined by clinical questionnaire. Each visit the patient will be asked a subjective questionnaire which includes symptoms of irritation, tearing, photophobia, discharge, and decreased vision on a none to always scale. Symptomatic resolution of viral conjunctivitis will be considered when the patient answers "rarely" to the list of symptoms. The time to resolution will then be compared.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861728


Contacts
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Contact: Andrew J Rong, MD 3053266000 ajr211@med.miami.edu

Locations
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United States, Florida
University of Miami Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Wendy Lee, MD    305-326-6434    wlee@med.miami.edu   
Principal Investigator: Wendy Lee, MD         
Sponsors and Collaborators
University of Miami
Novabay Pharmaceuticals
Investigators
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Principal Investigator: Wendy Lee, MD Bascom Palmer Eye Institute, University of Miami
Publications of Results:
Other 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

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Responsible Party: Wendy Lee, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03861728    
Other Study ID Numbers: 20170064
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Conjunctivitis, Viral
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Eye Infections, Viral
Virus Diseases
Eye Infections