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Viral Conjunctivitis Treatment Study

NCT ID: NCT03861728

Last Updated: 2021-12-29

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-14

Study Completion Date

2020-02-08

Brief Summary

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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.

Detailed Description

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Conditions

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Viral Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
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.

Study Groups

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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

Group Type EXPERIMENTAL

0.01% Hypochlorous acid

Intervention Type DEVICE

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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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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)

Intervention Type DEVICE

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Avenova Basic Sterile Saline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NovaBay Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Wendy Lee

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wendy Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Bascom Palmer Eye Institute, University of Miami

Locations

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University of Miami Bascom Palmer Eye Institute

Miami, Florida, United States

Site Status

Countries

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United States

References

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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

Reference Type 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.

Reference Type RESULT
PMID: 18677274 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20170064

Identifier Type: -

Identifier Source: org_study_id