Ocular Comfort and Markers of Inflammation in Subjects Undergoing Lid Hygiene Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Blepharitis
- Sponsor
- Minnesota Eye Consultants, P.A.
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Change in Severity of Markers of Inflammation
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change in Severity of Markers of Inflammation
Time Frame: 30 days
Clinical parameters include meibomian gland evaluation
Change in Severity of Markers of Inflammation using tear osmolarity.
Time Frame: 30 days
Clinical parameters include tear osmolarity.
Change in Ocular Discomfort
Time Frame: 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.