Ocular Comfort and Inflammation in Lid Hygiene Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ocular Comfort and Markers of Inflammation in Subjects Undergoing Lid Hygiene Therapy

Conditions
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Blepharitis

Intervention / Treatment
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* Device: Avenova Lid Cleanser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Eye<br>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. | Device: Avenova Lid Cleanser<br>* Avenova lid cleanser is an FDA-cleared saline solution preserved with 0.01% pure hypochlorous acid.<br>|
| No Intervention: Non-Treatment Eye<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Severity of Markers of Inflammation | Clinical parameters include prevalence of demodex mites. | 30 days | 
| Change in Severity of Markers of Inflammation | Clinical exam parameters include prevalence of tear film break up time. | 30 days | 
| Change in Severity of Markers of Inflammation | Clinical exam parameters include corneal and conjunctival staining. | 30 days | 
| Change in Severity of Markers of Inflammation | Clinical parameters include evaluation of meibomian gland including evaluation of lipid layer thickness.. | 30 days | 
| Change in Severity of Markers of Inflammation using tear osmolarity. | Clinical parameters include tear osmolarity. | 30 days | 
| Change in Severity of Markers of Inflammation | Clinical parameters include tear ferning patterns. | 30 days | 
| Change in Severity of Markers of Inflammation | Clinical parameters include meibomian gland evaluation | 30 days | 
| Change in Ocular Discomfort | Change in ocular discomfort based on scores from Eyelid Inflammation questionnaire. | 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. | 30 days |