Ocular Comfort and Inflammation in Lid Hygiene Therapy

Not Applicable

Terminated

• Conditions: Blepharitis
• Interventions: Device: Avenova Lid Cleanser

• Registration Number: NCT02938078
• Lead Sponsor: Minnesota Eye Consultants, P.A.

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-19
• Primary Completion: 2018-08-24
• Study Completion: 2018-08-24
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-17
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Eye	Avenova Lid Cleanser	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.

Primary Outcome Measures

Name	Time	Method
Change in Severity of Markers of Inflammation	30 days	Clinical parameters include meibomian gland evaluation
Change in Severity of Markers of Inflammation using tear osmolarity.	30 days	Clinical parameters include tear osmolarity.
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.

Trial Locations

Locations (1)

Minnesota eye Consultants, PA; 🇺🇸 Bloomington, Minnesota, United States