Viral Conjunctivitis Treatment Study

Not Applicable

Terminated

• Conditions: Viral Conjunctivitis
• Interventions: Device: 0.01% Hypochlorous acid; Other: Placebo

• Registration Number: NCT03861728
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-11-14
• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-04
• Primary Completion: 2020-02-08
• Study Completion: 2020-02-08
• Disposition First Submitted: 2021-07-20
• Disposition First Submitted QC: 2021-07-20
• Disposition First Posted: 2021-07-26
• Status Verified: 2021-11
• Results First Submitted: 2021-11-29
• Results First Submitted QC: 2021-11-29
• Last Update Submitted: 2021-11-29
• Results First Posted: 2021-12-29
• Last Update Posted: 2021-12-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Viral Conjunctivitis Treatment	0.01% Hypochlorous acid	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
Viral Conjunctivitis Placebo	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Resolution of Viral Conjunctivitis	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 Outcome Measures

Name	Time	Method
Number of Participants With Symptomatic Resolution of Viral Conjunctivitis	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	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)

Trial Locations

Locations (1)

University of Miami Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States