Clinical trial NCT02938078: Ocular Comfort and Inflammation in Lid Hygiene Therapy
Official title: Ocular Comfort and Markers of Inflammation in Subjects Undergoing Lid Hygiene Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Blepharitis
Lead sponsor: Minnesota Eye Consultants, P.A.
Sponsor class: INDUSTRY
Collaborators: name: NovaBay Pharmaceuticals, Inc.
First posted: 2016-10-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Severity of Markers of Inflammation
timeFrame: 30 days
measure: Change in Severity of Markers of Inflammation
timeFrame: 30 days
measure: Change in Severity of Markers of Inflammation
timeFrame: 30 days
measure: Change in Severity of Markers of Inflammation
timeFrame: 30 days
measure: Change in Severity of Markers of Inflammation using tear osmolarity.
timeFrame: 30 days
measure: Change in Severity of Markers of Inflammation
timeFrame: 30 days
measure: Change in Severity of Markers of Inflammation
timeFrame: 30 days
measure: Change in Ocular Discomfort
timeFrame: 30 days
measure: Change in Ocular Discomfort
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Minnesota eye Consultants, PA
state: Minnesota
Study officials:
affiliation: Minnesota Eye Consultants
name: Ahmad M Fahmy, OD
role: PRINCIPAL_INVESTIGATOR
References: