Avenova for the Treatment of Viral Conjunctivitis
Phase: NA
Conditions: Viral Conjunctivitis
Sponsor: University of Miami

 
 
 
Viral Conjunctivitis 
Treatment Study 
NCT03861728  IRB STUDY NUMBER: 20170064 
VERSION 7, DATE: 11/29/21 

IRB Study Number:20170064 
Version 7, Date: 11/29/21 
 
 
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1) 
Protocol Title 
Treatment of Viral Conjunctivitis with Avenova ® (0.01% hypochlorous 
acid)  
2) 
Objectives 
The objective of this study is to determine the efficacy Avenova® (0.01% 
hypochlorous acid) in the treatment of viral conjunctivitis. We hypothesize 
that patients treated with Avenova® will have a quicker resolution of their 
ocular signs and symptoms of Viral Conjunctivitis.  
3) 
Background 
Avenova® is a proprietary pure hypochlorous acid under a family of skin 
cleansing products by NovaBay that has been approved by the FDA as a 
510(k) medical device. Many in vitro studies have evaluated the efficacy 
of hypochlorous acid against bacterial 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. (See included supplemental “Material 
safety data sheet”) 
We propose a study to evaluate the role of Avenova® (0.1% hypochlorous 
acid) in the treatment of common ocular viral infections. 
4) 
Inclusion and Exclusion Criteria* 
Inclusion:  
Patients who present to Bascom Palmer Eye Institute with a clinical 
diagnosis of viral conjunctivitis will be allowed to participate in the study. 
Patients with viral conjunctivitis will be diagnosed clinically with 
symptoms of either unilateral or bilateral conjunctivitis of less than 1 week 
duration. These diagnoses will then be confirmed with a viral PCR. These 
patients will also need to have one of the following: 1. follicular 
conjunctivitis of the inferior tarsal conjunctiva, 2. mucoid discharge, 3. 
preauricular lymphadenopathy, or 4. associated upper respiratory 
symptoms.  
Exclusion:  
Patients with a history of allergic conjunctivitis, history of herpetic eye 
disease, concurrent diagnosis of bacterial conjunctivitis, purulent 
discharge, intraocular inflammation, or current contact lens use will be 
excluded from the study. Immunocompromised/Immunosupressed 
patients, patients with HIV, pregnant women, prisoners, or adults who are 
unable to provide consent will be excluded. Age less than 18 years old will 
be excluded viral conjunctivitis treatment arm of the study. 

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5) 
Number of Subjects* 
Total number of subjects to be enrolled is 125 
6) 
Study-Wide Recruitment Methods* 
N/A.  
7) 
Study Timelines* 
Patients will participate for 3 weeks in total. Enrollment will be complete 
by 2 years and the primary analyses will be completed in 2.5 years 
duration.  
8) 
Study Endpoints* 
The primary endpoint of the study is the resolution of follicular 
conjunctivitis and symptomatic improvement in the viral conjunctivitis 
arm.  
9) 
Procedures Involved* 
Patients will be diagnosed by clinical exam in the Bascom Palmer 
Emergency Department. Those meeting inclusion criteria will be 
randomized to Avenova® spray vs artificial tears (placebo), to be used in 
the affected eye four times a day for two weeks duration in total. Samples 
of the tears from the ocular surface and conjunctiva will be obtained 
through cotton swabs from the patient’s initial visit and daily to every-
other-day through 1 week, and finally at week 2 (e.g. Day 0, 1, 2, 3, 4, 5, 
6, 7, and 14 +/- 1 day). These samples will be obtained in both groups 
(Avenova® spray and artificial tears). Collected samples will be sent to 
the Bascom Palmer Microbiology laboratory for PCR evaluation and 
microbiology evaluation and then promptly disposed of. Patients will 
return once every week for 3 weeks duration in order to assess for 
resolution of follicular conjunctivitis and symptomatic relief based off the 
subjective scoring guidelines (see supplemental material) as well as 
physical exam findings (lymphadenopathy, follicular conjunctivitis, 
injection, discharge, subepithelial infiltrates, conjunctival 
pseudomembranes) See Objective Questionnaire. Patients will be 
questioned about adverse effect to treatment each visit and be assessed for 
surrounding periorbital dermatitis. However, Avenova® has a wide range 
of indications for use and is approved by the FDA as a medical device for 
use on the skin.  
 
10) Data Management* 
Viral conjunctivitis 
POWER ANALYSIS: 
%spontaneous resolution in 7 days: 20% 
%Resolution with treatment: 50% 

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 N=39 for each treatment group for power of 80% 
Data will include medical record number, diagnosis, type of therapy, 
commentary on improvement/worsening of signs and symptoms. It will 
also include adverse events.  
Research data can only be accessed by clinicians (whose names have been 
added to the IRB) in direct care of the patient or those listed on the IRB. 
All identifiable data will be stored on a locked and encrypted USB drive 
and will be de-identified of personal identifying information at the 
conclusion of the study once all data is analyzed, which will again be 
stored on a locked and encrypted USB drive. The investigatory team will 
assign subject identifiers and study records will be locked in the office of 
Dr. Lee on the 4th floor Suite 450M of the Bascom Palmer Eye Institute 
located at 900 NW 17th Street, Miami, FL 33136. 
11) Provisions to Monitor the Data to Ensure the Safety of Subjects* 
Subjects will return for follow up appointments at weekly intervals for three weeks 
total. It is safe to monitor these patients at these intervals as these viral infections 
are self-limiting and often resolve with time. As there is currently no treatment for 
these infections, observation and symptomatic management is standard of practice.  
 
Co-investigators on the study will assess patients at each of the follow-up visits for 
any side effects (listed in the informed consent) to the assigned medical treatment 
and document this in the electronic medical health record. Patients will be given the 
telephone number of a principle investigator if they believe they are having a 
significant side effect or may also present at the 24 hour emergency department at 
the Bascom Palmer Eye Institute. If there are noted adverse reactions to the device, 
participation in the study will be terminated for that individual patient. Data will be 
analyzed by members of the IRB team at weekly intervals, and if during the study, 
greater than 20% of patients are observed to have an adverse reaction to the spray, 
the study will be terminated prematurely. 
 
12) Withdrawal of Subjects* 
Patients will be withdrawn from the study if the physician deems their 
symptoms to be clinically related to administration of the device.  Patients 
may withdraw voluntarily from the study at any time, but will be 
continued to be followed for the duration of the study. Non-compliant 
patients (those who do not take the study device) will be allowed to 
continue in their respective groups (Avenova® versus artificial tears) for 
the duration of the study.  
13) Risks to Subjects* 
Avenova® (0.1% hypochlorous acid) has been extensively studied and has 
been approved by the FDA as a 510(k) medical device wound cleanser for 
any skin and undergone extensive in-vitro toxicity testing. In 
ophthalmology, it is commonly used as a lid cleanser in the treatment of 

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blepharitis and meibomian gland dysfunction. It is applied directly to the 
lid margin and has an excellent safety profile. There has been no noted 
ocular side effects, which includes a lack of ocular irritation. (see included 
“Material safety data sheet”) 
We see no foreseeable risk to the artificial tear group.  
There is no foreseeable risk of obtaining the cotton swabs from the 
conjunctiva. These tests will be performed without adding additional costs 
to the patient. 
Exclusion criteria include pregnancy and thus this group would not be 
included in the study. Those who may become pregnant during the study 
may choose to leave the study—however the topical spray is safe to be 
used in pregnancy.  
14) Potential Benefits to Subjects* 
Benefits to patients would include earlier resolution of lesions and 
discomfort from conjunctivitis compared to control. These treatments 
could shorten duration of viral conjunctivitis, a common and extremely 
contagious viral infection that stops patients from carrying out their 
normal activities. If our study shows a shortened duration of infection 
from this therapy, it could result in symptomatic relief from the effects of 
viral conjunctivitis for which there have been no beneficial treatments at 
present. 
15) Vulnerable Populations* 
Not applicable 
 
16) Setting 
Bascom Palmer Eye Institute is an ophthalmic hospital with a 24 hour 
emergency department specializing in ophthalmic disease.  Research will 
be collected as the patient is followed in the emergency department as well 
as by physicians staffing clinic.   
17) Resources Available 
Bascom Palmer Eye Institute is an ophthalmic hospital with a 24 hour 
emergency department specializing in ophthalmic disease. The institute 
receives a wide referral base including all of Florida and the surrounding 
sites, as well as numerous international referrals due to its prominence in 
the field of ophthalmology. This institute is staffed with residents, fellows 
and attending’s, all specialized only in the field of ophthalmology. Each 
week, the emergency department diagnoses at least 10 cases of viral 
conjunctivitis. If half of these cases agree to participate in the study, there 
will be adequate number of patients to power the study.  
Before the start of the study, all participating members will be informed of 
the study, as well as possible risks, benefits and their role within the study. 

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We plan to devote 24 months to collecting patients as well as the statistical 
analysis for the study.  
18) Recruitment Methods 
Patients will be recruited from the Bascom Palmer Eye institute 
emergency department as a referral. Potential subjects are those identified 
as being infected with viral conjunctivitis by the ophthalmologist. There 
will be no advertisements for this study and no payment will be offered to 
participants of the study. If the patient consents to the study, he/she will be 
randomly assigned to Avenova® vs artificial tears through a 
randomization computer program.  
19) Confidentiality 
Identifiable data will be stored on a locked and encrypted USB drive to be locked 
in the office of Dr. Lee on the 4th floor Suite 450M of the Bascom Palmer Eye 
Institute located at 900 NW 17th Street, Miami, FL 33136. This data will be de-
identified of personal identifying information at the conclusion of the study. The 
investigatory team will assign subject identifiers and study records will only be 
accessed by the study coordinators.  
 
20) Provisions to Protect the Privacy Interests of Subjects 
To limit intrusiveness to patients, data will only be collected during clinic follow-up 
(once every week for three weeks). Patients will receive a subjective questionnaire 
(see supplemental material) each visit to ensure consistency between patients and 
between visits. The research team will then review the data collected through these 
questionnaires for analysis.  
  
21) Compensation for Research-Related Injury 
Patients will not be compensated for research related injuries. This will be 
written in the consent and described to the patient before participation in 
the study. 
22) Economic Burden to Subjects 
The device will be provided free of cost to patients as provided by 
Novabay. Also, there is no cost to participants for the collection of tears 
via the use of cotton swab.  
23) Consent Process 
Consent will be obtained during an Emergency Room visit by the 
physician and will follow the SOP: Informed Consent Process for 
Research (HRP-090). The informed consent will occur that same visit to 
the ER; if the patient decides that he/she does not want to participate, 
he/she will be unable to participate at a later visit. Each visit, the patient 
will be asked and have the option to leave the study.  
Non-English Speaking Subjects 

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• Spanish will be used to obtain consent in those who prefer the Spanish 
language—translation will be offered if needed with consent offered in 
the Spanish language.  
24) Process to Document Consent in Writing 
Eligible subjects will be informed of the nature, risks, and benefits of the study and 
informed that they are not required to participate. If interested in participating, they 
will be given the consent form to read, asked if they have any questions or need 
further explanations, and will have the option of taking the consent form home to 
have more time to decide about participating.  
The consent process will be obtained by one of the research team members whose 
name and signature will be mentioned in the consent form. The details of the study 
will be explained to the prospective subjects. 
 
 
25) Drugs or Devices 
The device will be stored, handled and dispensed by the Bascom Palmer 
Pharmacy and the designated IRB study team members. The device will 
be administered by the patient. Avenova® has received FDA approval as a 
510(k) medical device with a wide range of indications including for use 
on the skin surface. Note: although Novabay has been described as a 
funding source, only Avenova® will be provided, no direct funding will 
be provided.  
 
References 
  
1. Kim HJ, Lee JG, Kang JW, Cho HJ, Kim HS, Byeon HK, Yoon Effects of a low 
concentration hypochlorous acid nasal irrigation solution on bacteria, fungi, and 
virus. H.Laryngoscope. 2008 Oct;118(10):1862-7 
2. 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.