Viral Conjunctivitis Treatment Study

Study Overview
=================
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.

Official Title
-----------------
Avenova for the Treatment of Viral Conjunctivitis

Conditions
-----------------
Viral Conjunctivitis

Intervention / Treatment
-----------------
* Device: 0.01% Hypochlorous acid
* Other: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Viral Conjunctivitis Treatment<br>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<br>* Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)<br>* Other names: Avenova;|
| Placebo Comparator: Viral Conjunctivitis Placebo<br>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<br>* Placebo to be used four times a day to the affected eye for 2 weeks<br>* 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 |