Ocular Comfort and Inflammation in Lid Hygiene Therapy

Minnesota Eye Consultants, P.A.

Status: Terminated

Conditions: Blepharitis

Treatments: Device: Avenova Lid Cleanser

Study type: Interventional

Funder types: Industry

Identifiers

NCT02938078

MEC-NBY-2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 2 patient groups

Treatment Eye

Experimental group

Description:

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.

Treatment:

Device: Avenova Lid Cleanser

Non-Treatment Eye

No Intervention group

Description:

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.