Ocular Comfort and Inflammation in Lid Hygiene Therapy

Sponsor

Minnesota Eye Consultants, P.A. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02938078

Collaborator

NovaBay Pharmaceuticals, Inc. (Industry)

Enrollment

Location

Arms

22.7

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blepharitis	Device: Avenova Lid Cleanser	N/A

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

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Aug 24, 2018

Actual Study Completion Date :

Aug 24, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Severity of Markers of Inflammation [30 days]
Clinical parameters include prevalence of demodex mites.
Change in Severity of Markers of Inflammation [30 days]
Clinical exam parameters include prevalence of tear film break up time.
Change in Severity of Markers of Inflammation [30 days]
Clinical exam parameters include corneal and conjunctival staining.
Change in Severity of Markers of Inflammation [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. [30 days]
Clinical parameters include tear osmolarity.
Change in Severity of Markers of Inflammation [30 days]
Clinical parameters include tear ferning patterns.
Change in Severity of Markers of Inflammation [30 days]
Clinical parameters include meibomian gland evaluation
Change in Ocular Discomfort [30 days]
Change in ocular discomfort based on scores from Eyelid Inflammation questionnaire.
Change in Ocular Discomfort [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minnesota eye Consultants, PA	Bloomington	Minnesota	United States	55431

Sponsors and Collaborators

Minnesota Eye Consultants, P.A.
NovaBay Pharmaceuticals, Inc.

Investigators

Principal Investigator: Ahmad M Fahmy, OD, Minnesota Eye Consultants

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Minnesota Eye Consultants, P.A.

ClinicalTrials.gov Identifier:

NCT02938078

Other Study ID Numbers:

MEC-NBY-2016

First Posted:

Oct 19, 2016

Last Update Posted:

Aug 20, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Blepharitis

Inflammation

Study Results

No Results Posted as of Aug 20, 2020