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COVID-19 Pandemic
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| Name | Class |
|---|---|
| NovaBay Pharmaceuticals, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viral Conjunctivitis Treatment | Experimental | 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 Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.01% Hypochlorous acid | Device | Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device) |
|
| 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 |
| 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" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Lee, MD | Bascom Palmer Eye Institute, University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 18677274 | Result | Kim HJ, Lee JG, Kang JW, Cho HJ, Kim HS, Byeon HK, Yoon JH. Effects of a low concentration hypochlorous Acid nasal irrigation solution on bacteria, fungi, and virus. Laryngoscope. 2008 Oct;118(10):1862-7. doi: 10.1097/MLG.0b013e31817f4d34. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who received at least one dose of treatment or placebo and returned for follow up.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who received at least one dose of treatment or placebo and returned for follow up. | Posted | Count of Participants | Participants | Up to 8 days |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HSV Keratitis | Eye disorders | Systematic Assessment |
Early termination led to small numbers of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Lee | University of Miami | 305-326-6434 | wlee@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2021 | Nov 29, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003236 | Conjunctivitis, Viral |
| ID | Term |
|---|---|
| D015828 | Eye Infections, Viral |
| D015817 | Eye Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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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.
|
| Placebo | Other | Placebo to be used four times a day to the affected eye for 2 weeks |
|
|
| 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 |
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Duration of Symptoms Prior to Presentation | Median | Full Range | days |
|
| OG001 |
| 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 |
|
|
| 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" | All participants who received at least one dose of treatment or placebo and returned for follow up. | Posted | Count of Participants | Participants | Up to 8 days |
|
|
|
| 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) | All participants who received at least one dose of treatment or placebo and returned for follow up. | Posted | Count of Participants | Participants | Up to 8 days |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | 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 | 0 | 5 | 0 | 5 | 0 | 5 |
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| D003231 |
| Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |