Ocular Comfort and Inflammation in Lid Hygiene Therapy

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.

Study Overview

• Status: Terminated
• Conditions: Blepharitis
• Intervention / Treatment: Device: Avenova Lid Cleanser

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Bloomington, Minnesota, United States, 55431
      • Minnesota Eye Consultants, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Eye; 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; Avenova lid cleanser is an FDA-cleared saline solution preserved with 0.01% pure hypochlorous acid.
No Intervention: Non-Treatment Eye; 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?

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

Collaborators and Investigators

• Sponsor: Minnesota Eye Consultants, P.A.
• Collaborators: NovaBay Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Ahmad M Fahmy, OD, Minnesota Eye Consultants

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): August 24, 2018
• Study Completion (Actual): August 24, 2018

Study Registration Dates

• First Submitted: October 14, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Actual): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Eyelid Diseases; Inflammation; Blepharitis
• Other Study ID Numbers: MEC-NBY-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No