Viral ConjunctivitisNCT03861728
Viral Conjunctivitis Treatment Study
A study testing 0.01% Hypochlorous acid in people with Viral Conjunctivitis, run by University of Miami at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Viral Conjunctivitis
- What is being tested?
- 0.01% Hypochlorous acid
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2018to 8 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting to the Bascom Palmer Eye Institute
- Clinical diagnosis of viral conjunctivitis
- Symptoms less than 1 week duration
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Bascom Palmer Eye Institute
Miami, Florida, 33136
About this study
Official title: Avenova for the Treatment of Viral Conjunctivitis
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.
- Conditions
- Viral Conjunctivitis
- Being tested
- 0.01% Hypochlorous acid, Placebo
- Medical subject headings
- Conjunctivitis, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.01% Hypochlorous acidDevice
Also called Avenova
Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)
PlaceboOther
Also called Basic Sterile Saline
Placebo to be used four times a day to the affected eye for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 days
Secondary outcomes (2)
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"
Measured: 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)
Measured: Up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start14 Nov 2018
- Primary completion8 Feb 2020
- Study completion8 Feb 2020
Why it stopped: COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Viral ConjunctivitisStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- NovaBay Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Wendy Lee, University of Miami
- Investigators
- Wendy Lee, MD, Principal investigator, Bascom Palmer Eye Institute, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861728
- Sponsor's protocol ID
- 20170064
- Status last verified
- Nov 2021
- First submitted
- 11 Dec 2018
- Last updated
- 29 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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
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.
PubMed 18677274
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avenova for the Treatment of Viral Conjunctivitis
- ClinicalTrials.gov ID
- NCT03861728
- Acronym / sponsor ID
- 20170064
- Conditions
- Viral Conjunctivitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 Pandemic
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- NovaBay Pharmaceuticals, Inc.
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 8 Feb 2020 (actual)
- Study completion
- 8 Feb 2020 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Posted 29 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viral Conjunctivitis Treatment | Experimental | Device: 0.01% Hypochlorous acidPatients 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 | Other: PlaceboPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting to the Bascom Palmer Eye Institute
- Clinical diagnosis of viral conjunctivitis
- Symptoms less than 1 week duration
Key exclusion criteria (8 listed)
- history of allergic conjunctivitis
- history of herpetic eye disease
- concurrent diagnosis of bacterial conjunctivitis (based off microbiology plating)
- Immunocompromised / Immunosuppressed patients
- Patients with HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.01% Hypochlorous acidAlso: AvenovaRandomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device) | Device | Viral Conjunctivitis Treatment |
| PlaceboAlso: Basic Sterile SalinePlacebo to be used four times a day to the affected eye for 2 weeks | Other | Viral Conjunctivitis Placebo |
Primary outcome
Number of Participants With Clinical Resolution of Viral Conjunctivitis
Time frame: 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.
2 secondary outcomes
Number of Participants With Symptomatic Resolution of Viral Conjunctivitis
Time frame: Up to 8 days
Number of Participants With Undetectable Adenoviral DNA
Time frame: Up to 8 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundDebabov 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
- Results publication: PubMed 18677274Kim 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Lee, MD principal investigator
Bascom Palmer Eye Institute, University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.01% Hypochlorous acid in people with Viral Conjunctivitis, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinical Resolution of Viral Conjunctivitis (time frame: Up to 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03861728, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.