Blepharitis
Conditions
Brief 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.
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.
Interventions
DEVICEAvenova Lid Cleanser
Avenova lid cleanser is an FDA-cleared saline solution preserved with 0.01% pure hypochlorous acid.
Sponsors
NovaBay Pharmaceuticals, Inc.
Minnesota Eye Consultants, P.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Markers of Inflammation | 30 days | Clinical parameters include prevalence of demodex mites. |
| Change in Severity of Markers of Inflammation using tear osmolarity. | 30 days | Clinical parameters include tear osmolarity. |
| Change in Ocular Discomfort | 30 days | Change in ocular discomfort based on scores from Eyelid Inflammation questionnaire. |
Countries
United States
Outcome results
None listed