Ocular Comfort and Inflammation in Lid Hygiene Therapy
Primary Purpose
Blepharitis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Avenova Lid Cleanser
Sponsored by
About this trial
This is an interventional treatment trial for Blepharitis
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
Sites / Locations
- Minnesota eye Consultants, PA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment Eye
Non-Treatment Eye
Arm 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.
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.
Outcomes
Primary Outcome Measures
Change in Severity of Markers of Inflammation
Clinical parameters include prevalence of demodex mites.
Change in Severity of Markers of Inflammation
Clinical exam parameters include prevalence of tear film break up time.
Change in Severity of Markers of Inflammation
Clinical exam parameters include corneal and conjunctival staining.
Change in Severity of Markers of Inflammation
Clinical parameters include evaluation of meibomian gland including evaluation of lipid layer thickness..
Change in Severity of Markers of Inflammation using tear osmolarity.
Clinical parameters include tear osmolarity.
Change in Severity of Markers of Inflammation
Clinical parameters include tear ferning patterns.
Change in Severity of Markers of Inflammation
Clinical parameters include meibomian gland evaluation
Change in Ocular Discomfort
Change in ocular discomfort based on scores from Eyelid Inflammation questionnaire.
Change in Ocular Discomfort
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02938078
First Posted
October 14, 2016
Last Updated
August 17, 2020
Sponsor
Minnesota Eye Consultants, P.A.
Collaborators
NovaBay Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02938078
Brief Title
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
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Study Start Date
October 2016 (Actual)
Primary Completion Date
August 24, 2018 (Actual)
Study Completion Date
August 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minnesota Eye Consultants, P.A.
Collaborators
NovaBay Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Eye
Arm Type
Experimental
Arm 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.
Arm Title
Non-Treatment Eye
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Avenova Lid Cleanser
Intervention Description
Avenova lid cleanser is an FDA-cleared saline solution preserved with 0.01% pure hypochlorous acid.
Primary Outcome Measure Information:
Title
Change in Severity of Markers of Inflammation
Description
Clinical parameters include prevalence of demodex mites.
Time Frame
30 days
Title
Change in Severity of Markers of Inflammation
Description
Clinical exam parameters include prevalence of tear film break up time.
Time Frame
30 days
Title
Change in Severity of Markers of Inflammation
Description
Clinical exam parameters include corneal and conjunctival staining.
Time Frame
30 days
Title
Change in Severity of Markers of Inflammation
Description
Clinical parameters include evaluation of meibomian gland including evaluation of lipid layer thickness..
Time Frame
30 days
Title
Change in Severity of Markers of Inflammation using tear osmolarity.
Description
Clinical parameters include tear osmolarity.
Time Frame
30 days
Title
Change in Severity of Markers of Inflammation
Description
Clinical parameters include tear ferning patterns.
Time Frame
30 days
Title
Change in Severity of Markers of Inflammation
Description
Clinical parameters include meibomian gland evaluation
Time Frame
30 days
Title
Change in Ocular Discomfort
Description
Change in ocular discomfort based on scores from Eyelid Inflammation questionnaire.
Time Frame
30 days
Title
Change in Ocular Discomfort
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad M Fahmy, OD
Organizational Affiliation
Minnesota Eye Consultants
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minnesota eye Consultants, PA
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ocular Comfort and Inflammation in Lid Hygiene Therapy
We'll reach out to this number within 24 hrs