Ocular Comfort and Inflammation in Lid Hygiene Therapy

Blepharitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02938078
• Other study ID #: MEC-NBY-2016
• Status: Terminated
• Phase: N/A
• Start date: October 2016
• Est. completion date: August 24, 2018

Study information

• Verified date: August 2020
• Source: Minnesota Eye Consultants, P.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: August 24, 2018
• Est. primary completion date: August 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharitis
• Inflammation

Intervention

Device:
• Avenova Lid Cleanser
Avenova lid cleanser is an FDA-cleared saline solution preserved with 0.01% pure hypochlorous acid.

Locations

Country	Name	City	State
United States	Minnesota eye Consultants, PA	Bloomington	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minnesota Eye Consultants, P.A.	NovaBay Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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