Viral Conjunctivitis Treatment Study

Overview

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.

Full Title of Study: “Avenova for the Treatment of Viral Conjunctivitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: February 8, 2020

Interventions

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

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Clinical Resolution of Viral Conjunctivitis
    • Time Frame: Up to 8 days
    • 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 Measures

  • Number of Participants With Symptomatic Resolution of Viral Conjunctivitis
    • Time Frame: Up to 8 days
    • 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
    • Time Frame: Up to 8 days
    • This is the number of participants who on day 7 (+/-1 days) had undetectable adenoviral DNA by quantitative Polymerase Chain Reaction (qPCR) (Ct > 35)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Miami
  • Collaborator
    • NovaBay Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wendy Lee, Associate Professor – University of Miami
  • Overall Official(s)
    • Wendy Lee, MD, Principal Investigator, Bascom Palmer Eye Institute, University of Miami

References

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

Citations Reporting on Results

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.

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