Viral Conjunctivitis
Conditions
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.
Interventions
DEVICE0.01% 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)
OTHERPlacebo
Placebo to be used four times a day to the affected eye for 2 weeks
Sponsors
NovaBay Pharmaceuticals, Inc.
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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) | 6 |
| 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
Placebo: Placebo to be used four times a day to the affected eye for 2 weeks | 5 |
| Total | 11 |
Baseline characteristics
| Characteristic | Viral Conjunctivitis Treatment | Viral Conjunctivitis Placebo | Total |
|---|---|---|---|
| Age, Continuous | 40 years | 48 years | 40 years |
| Duration of Symptoms Prior to Presentation | 3 days | 1 days | 3 days |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 1 / 6 | 0 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 |
Outcome results
Primary
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.
Time frame: Up to 8 days
Population: All participants who received at least one dose of treatment or placebo and returned for follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Viral Conjunctivitis Treatment | Number of Participants With Clinical Resolution of Viral Conjunctivitis | 3 Participants |
| Viral Conjunctivitis Placebo | Number of Participants With Clinical Resolution of Viral Conjunctivitis | 3 Participants |
Secondary
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
Time frame: Up to 8 days
Population: All participants who received at least one dose of treatment or placebo and returned for follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Viral Conjunctivitis Treatment | Number of Participants With Symptomatic Resolution of Viral Conjunctivitis | 2 Participants |
| Viral Conjunctivitis Placebo | Number of Participants With Symptomatic Resolution of Viral Conjunctivitis | 4 Participants |
Secondary
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)
Time frame: Up to 8 days
Population: All participants who received at least one dose of treatment or placebo and returned for follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Viral Conjunctivitis Treatment | Number of Participants With Undetectable Adenoviral DNA | 3 Participants |
| Viral Conjunctivitis Placebo | Number of Participants With Undetectable Adenoviral DNA | 1 Participants |