Ocular Comfort and Inflammation in Lid Hygiene Therapy

NCT ID: NCT02938078

Last Updated: 2020-08-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-08-24

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.

Conditions

Blepharitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Avenova Lid Cleanser

Intervention Type: DEVICE

Avenova lid cleanser is an FDA-cleared saline solution preserved with 0.01% pure hypochlorous acid.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Avenova Lid Cleanser

Avenova lid cleanser is an FDA-cleared saline solution preserved with 0.01% pure hypochlorous acid.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NovaBay Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Minnesota Eye Consultants, P.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmad M Fahmy, OD

Role: PRINCIPAL_INVESTIGATOR

Minnesota Eye Consultants

Locations

Minnesota eye Consultants, PA

Bloomington, Minnesota, United States

Countries

United States

Other Identifiers

MEC-NBY-2016

Identifier Type: -

Identifier Source: org_study_id