BlepharitisNCT02938078
Ocular Comfort and Inflammation in Lid Hygiene Therapy
A study testing Avenova Lid Cleanser in people with Blepharitis, run by Minnesota Eye Consultants, P.A. at 1 site in United States.
Trial summary
The primary study objectives are: to evaluate (1) the change in ocular discomfort at 30 days and (2) the change in signs and symptoms of ocular surface disease in demodex-positive subjects beginning the use of Avenova. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharitis
- What is being tested?
- Avenova Lid Cleanser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 24 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subject signed and dated a IRB-approved informed consent document
- Mild or greater Demodex (minimum 15 observable mites in six lashes)
- Score of 20 or more on the OSDI Questionnaire
- Score of 20 or more on the Eyelid Inflammation Questionnaire
Who cannot join
- Currently enrolled in another prospective research study
- Unable to attend two follow-up visits over 30 days
- Current allergic conjunctivitis of the cornea, conjunctiva, or eyelid in either eye
- Prior ocular trauma where surgery was indicated
- Prior corneal transplant in either eye
- Any ocular surgery within the past six months
Show all 20Show fewer
- Abnormal corneal scarring, erosions, or Stevens-Johnson syndrome
- Anticipation of ocular surgery within the next 30 days
- Non-English speaking
- Pregnant, nursing, or expect to become pregnant within the next 30 days
- Known sensitivity to chlorine or Avenova
- Moderate, or severe conjunctivochalasis
- Contact lenses within the last 30 days and unwilling to discontinue for 30 days
- Use of topical cyclosporine for less than 6 continuous months prior to baseline
- Procedure such as pulsed light or commercial lid massage in last 30 days
- Known history of autoimmune disease
- Punctal plugs placed within the last 30 days
- Use of Avenova or other lid cleansers within the last 30 days
- Changes in systemic or ocular medications in the last 30 days
- Unwilling to commit to the same ocular and systemic medications for 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Minnesota eye Consultants, PA
Bloomington, Minnesota, 55431
About this study
Official title: Ocular Comfort and Markers of Inflammation in Subjects Undergoing Lid Hygiene Therapy
The primary study objectives are: to evaluate (1) the change in ocular discomfort at 30 days and (2) the change in signs and symptoms of ocular surface disease in demodex-positive subjects beginning the use of Avenova.
Read the detailed description
This is a prospective study of subjects who have been diagnosed with bilateral demodex blepharitis. Qualified symptomatic eyes will be randomized and monitored for 30 days; one eye will undergo Avenova treatment twice daily and one eye will not undergo any study treatment.
- Conditions
- Blepharitis
- Being tested
- Avenova Lid Cleanser
- Medical subject headings
- Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avenova Lid CleanserDevice
Avenova lid cleanser is an FDA-cleared saline solution preserved with 0.01% pure hypochlorous acid.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Eye | Experimental | One eye will be treated with Avenova; the other eye will not be treated. The investigator is masked as to which eye is receiving Avenova product. Receives: Device: Avenova Lid Cleanser |
| Non-Treatment Eye | No intervention | One eye will be treated with Avenova; the other eye will not will be treated. The investigator is masked as to which eye is receiving Avenova product. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Severity of Markers of Inflammation
Clinical parameters include prevalence of demodex mites.
Measured: 30 days
Change in Severity of Markers of Inflammation
Clinical exam parameters include prevalence of tear film break up time.
Measured: 30 days
Change in Severity of Markers of Inflammation
Clinical exam parameters include corneal and conjunctival staining.
Measured: 30 days
Change in Severity of Markers of Inflammation
Clinical parameters include evaluation of meibomian gland including evaluation of lipid layer thickness..
Measured: 30 days
Change in Severity of Markers of Inflammation using tear osmolarity.
Clinical parameters include tear osmolarity.
Measured: 30 days
Change in Severity of Markers of Inflammation
Clinical parameters include tear ferning patterns.
Measured: 30 days
Change in Severity of Markers of Inflammation
Clinical parameters include meibomian gland evaluation
Measured: 30 days
Change in Ocular Discomfort
Change in ocular discomfort based on scores from Eyelid Inflammation questionnaire.
Measured: 30 days
Change in Ocular Discomfort
Change in ocular discomfort based on scores from Ocular Surface Disease Index questionnaire. Scored on a scale of 0-100, with higher scores indicating greater disability.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion24 Aug 2018
- Study completion24 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharitisStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minnesota Eye Consultants, P.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NovaBay Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Ahmad M Fahmy, OD, Principal investigator, Minnesota Eye Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938078
- Sponsor's protocol ID
- MEC-NBY-2016
- Status last verified
- Aug 2020
- First submitted
- 14 Oct 2016
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Comfort and Markers of Inflammation in Subjects Undergoing Lid Hygiene Therapy
- ClinicalTrials.gov ID
- NCT02938078
- Acronym / sponsor ID
- MEC-NBY-2016
- Conditions
- Blepharitis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Minnesota Eye Consultants, P.A.Industry (pharma, biotech, devices)
- Collaborators
- NovaBay Pharmaceuticals, Inc.
- Study start
- Oct 2016 (actual)
- Primary completion
- 24 Aug 2018 (actual)
- Study completion
- 24 Aug 2018 (actual)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary study objectives are: to evaluate (1) the change in ocular discomfort at 30 days and (2) the change in signs and symptoms of ocular surface disease in demodex-positive subjects beginning the use of Avenova.
Detailed description
This is a prospective study of subjects who have been diagnosed with bilateral demodex blepharitis. Qualified symptomatic eyes will be randomized and monitored for 30 days; one eye will undergo Avenova treatment twice daily and one eye will not undergo any study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Eye | Experimental | Device: Avenova Lid CleanserOne eye will be treated with Avenova; the other eye will not be treated. The investigator is masked as to which eye is receiving Avenova product. |
| Non-Treatment Eye | No intervention | –One eye will be treated with Avenova; the other eye will not will be treated. The investigator is masked as to which eye is receiving Avenova product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject signed and dated a IRB-approved informed consent document
- Mild or greater Demodex (minimum 15 observable mites in six lashes)
- Score of 20 or more on the OSDI Questionnaire
- Score of 20 or more on the Eyelid Inflammation Questionnaire
Key exclusion criteria (20 listed)
- Currently enrolled in another prospective research study
- Unable to attend two follow-up visits over 30 days
- Current allergic conjunctivitis of the cornea, conjunctiva, or eyelid in either eye
- Prior ocular trauma where surgery was indicated
- Prior corneal transplant in either eye
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 |
|---|---|---|
| Avenova Lid CleanserAvenova lid cleanser is an FDA-cleared saline solution preserved with 0.01% pure hypochlorous acid. | Device | Treatment Eye |
Primary outcome
Change in Severity of Markers of Inflammation
Time frame: 30 days
Clinical parameters include prevalence of demodex mites.
Change in Severity of Markers of Inflammation
Time frame: 30 days
Clinical exam parameters include prevalence of tear film break up time.
Change in Severity of Markers of Inflammation
Time frame: 30 days
Clinical exam parameters include corneal and conjunctival staining.
Change in Severity of Markers of Inflammation
Time frame: 30 days
Clinical parameters include evaluation of meibomian gland including evaluation of lipid layer thickness..
Change in Severity of Markers of Inflammation using tear osmolarity.
Time frame: 30 days
Clinical parameters include tear osmolarity.
Change in Severity of Markers of Inflammation
Time frame: 30 days
Clinical parameters include tear ferning patterns.
Change in Severity of Markers of Inflammation
Time frame: 30 days
Clinical parameters include meibomian gland evaluation
Change in Ocular Discomfort
Time frame: 30 days
Change in ocular discomfort based on scores from Eyelid Inflammation questionnaire.
Change in Ocular Discomfort
Time frame: 30 days
Change in ocular discomfort based on scores from Ocular Surface Disease Index questionnaire. Scored on a scale of 0-100, with higher scores indicating greater disability.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Ahmad M Fahmy, OD principal investigator
Minnesota Eye Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avenova Lid Cleanser in people with Blepharitis, run by Minnesota Eye Consultants, P.A. 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 4 inclusion and 20 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 20 Aug 2020. 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. 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?
The study was stopped early. Results are not available in the source record.
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?
Change in Severity of Markers of Inflammation (time frame: 30 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2020.