Viral Conjunctivitis Treatment Study

• Sponsor: University of Miami (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03861728
• Collaborator: NovaBay Pharmaceuticals, Inc. (Industry)
• Enrollment: 11
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.8
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Viral Conjunctivitis	Device: 0.01% Hypochlorous acid; Other: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Avenova for the Treatment of Viral Conjunctivitis
• Actual Study Start Date: Nov 14, 2018
• Actual Primary Completion Date: Feb 8, 2020
• Actual Study Completion Date: Feb 8, 2020

Arms and Interventions

Arm	Intervention/Treatment
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	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 Names: Avenova
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	Other: Placebo; Placebo to be used four times a day to the affected eye for 2 weeks; Other Names: Basic Sterile Saline

Outcome Measures

Primary Outcome Measures

1. 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

1. 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"

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Bascom Palmer Eye Institute	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami
• NovaBay Pharmaceuticals, Inc.

Investigators

• Principal Investigator: Wendy Lee, MD, Bascom Palmer Eye Institute, University of Miami

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 29, 2021

More Information

Publications

• 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

• Responsible Party: Wendy Lee, Associate Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT03861728
• Other Study ID Numbers: 20170064
• First Posted: Mar 4, 2019
• Last Update Posted: Dec 29, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Conjunctivitis, Viral; Conjunctivitis

Study Results

Participant Flow

Arm/Group Title	Viral Conjunctivitis Treatment	Viral Conjunctivitis Placebo
Arm/Group Description	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 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)	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 Placebo: Placebo to be used four times a day to the affected eye for 2 weeks
Period Title: Overall Study
STARTED	6	5
COMPLETED	6	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Viral Conjunctivitis Treatment	Viral Conjunctivitis Placebo	Total
Arm/Group Description	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 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)	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 Placebo: Placebo to be used four times a day to the affected eye for 2 weeks	Total of all reporting groups
Overall Participants	6	5	11
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	40	48	40
Sex: Female, Male (Count of Participants)
Female	1 16.7%	3 60%	4 36.4%
Male	5 83.3%	2 40%	7 63.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 50%	2 40%	5 45.5%
Not Hispanic or Latino	2 33.3%	3 60%	5 45.5%
Unknown or Not Reported	1 16.7%	0 0%	1 9.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	2 40%	2 18.2%
White	5 83.3%	3 60%	8 72.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 16.7%	0 0%	1 9.1%
Duration of Symptoms Prior to Presentation (days) [Median (Full Range) ]
Median (Full Range) [days]	3	1	3

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Clinical Resolution of Viral Conjunctivitis
Description	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.
Time Frame	Up to 8 days

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of treatment or placebo and returned for follow up.

Arm/Group Title	Viral Conjunctivitis Treatment	Viral Conjunctivitis Placebo
Arm/Group Description	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 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)	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 Placebo: Placebo to be used four times a day to the affected eye for 2 weeks
Measure Participants	6	5
Count of Participants [Participants]	3 50%	3 60%

2. Secondary Outcome

Title	Number of Participants With Symptomatic Resolution of Viral Conjunctivitis
Description	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"
Time Frame	Up to 8 days

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of treatment or placebo and returned for follow up.

Arm/Group Title	Viral Conjunctivitis Treatment	Viral Conjunctivitis Placebo
Arm/Group Description	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 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)	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 Placebo: Placebo to be used four times a day to the affected eye for 2 weeks
Measure Participants	6	5
Count of Participants [Participants]	2 33.3%	4 80%

3. Secondary Outcome

Title	Number of Participants With Undetectable Adenoviral DNA
Description	This is the number of participants who on day 7 (+/-1 days) had undetectable adenoviral DNA by quantitative Polymerase Chain Reaction (qPCR) (Ct > 35)
Time Frame	Up to 8 days

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of treatment or placebo and returned for follow up.

Arm/Group Title	Viral Conjunctivitis Treatment	Viral Conjunctivitis Placebo
Arm/Group Description	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 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)	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 Placebo: Placebo to be used four times a day to the affected eye for 2 weeks
Measure Participants	6	5
Count of Participants [Participants]	3 50%	1 20%

Adverse Events

Time Frame	3 weeks
Arm/Group Title	Viral Conjunctivitis Treatment		Viral Conjunctivitis Placebo
Arm/Group Description	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 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)		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 Placebo: Placebo to be used four times a day to the affected eye for 2 weeks
All Cause Mortality
	Viral Conjunctivitis Treatment		Viral Conjunctivitis Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/5 (0%)
Serious Adverse Events
	Viral Conjunctivitis Treatment		Viral Conjunctivitis Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Viral Conjunctivitis Treatment		Viral Conjunctivitis Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/6 (16.7%)		0/5 (0%)
Eye disorders
HSV Keratitis	1/6 (16.7%)	1	0/5 (0%)	0

Limitations/Caveats

Early termination led to small numbers of subjects analyzed

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.