Meibomian Gland Dysfunction Management
Primary Purpose
Contact Lens Discomfort, Meibomian Gland Dysfunction
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BlephEx
Manual debridement
Sponsored by
About this trial
This is an interventional treatment trial for Contact Lens Discomfort
Eligibility Criteria
Inclusion Criteria:
- Habitual contact lens wearers whose contact lens wear time has reduced due to MGD will be preferentially considered for this study. Subjects who currently cannot wear contact lenses due to MGD may be considered on a case-by-case basis.
Exclusion Criteria:
- Subjects who are currently using any prescription ophthalmic medications (such as antibiotics, steroids and immunomodulatory drugs) will be excluded from participation.
- Subjects who have active ocular infections will be excluded from participation.
Sites / Locations
- Rosenberg School of Optometry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BlephEx
Manual debridement
Arm Description
The subjects who are enrolled in this arm will undergo electronic lid margin debridement using the BlephEx instrument.
The subjects who are enrolled in this arm will undergo manual lid margin debridement using a stainless steel ophthalmic golf spud.
Outcomes
Primary Outcome Measures
Symptomatic relief
Betterment of symptoms (improvement in contact lens discomfort) will be measured using two different surveys - Ocular Surface Disease Index (OSID) and Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8). The OSDI scores can range from 0 to 100. The CLDEQ-8 scores can range from 0 to 37. In both the questionnaires, a lowering of the score during follow-up visits represents a betterment of symptoms suffered by the patient. The numerical change in the scores on these two questionnaires will be documented as the change in symptom profile of the patient (betterment / worsening / stability).
Secondary Outcome Measures
Meibography
Meibomian gland imaging will be performed to document any changes in the Meibomian gland during the study period.
Lissamine green staining grade of the lid margin
The lid margin will be stained with Lissamine green dye. For the purpose of this study, Lissamine green staining of the eyelid margins will be graded from 0 to 4. (Zero representing "normal" or "no" staining; Four representing the highest degree of staining). During the course of the study, a decrease in lid margin staining will indicate a betterment of the health of the eyelid margin.
Inflammatory activity
The presence or absence of Matrix Metalloproteinase-9 (MMP-9) in the tear fluid will be documented during the study visits. Presence of MMP-9 in the tear fluid indicates the presence of inflammatory activity in the tear fluid.
Tear break-up time
Improvement in non-invasive tear break-up time measurement will be an objective outcome of the study.
Full Information
NCT ID
NCT03652337
First Posted
June 19, 2018
Last Updated
September 4, 2018
Sponsor
University of the Incarnate Word
Collaborators
American Academy of Optometry
1. Study Identification
Unique Protocol Identification Number
NCT03652337
Brief Title
Meibomian Gland Dysfunction Management
Official Title
Meibomian Gland Dysfunction Management to Relieve Contact Lens Discomfort
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
April 10, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of the Incarnate Word
Collaborators
American Academy of Optometry
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare electronic debridement of the eyelid margin (BlephEx) to manual debridement of the eyelid margin as treatment options for patients intolerant to contact lens wear consequent to Meibomian gland dysfunction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Lens Discomfort, Meibomian Gland Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BlephEx
Arm Type
Experimental
Arm Description
The subjects who are enrolled in this arm will undergo electronic lid margin debridement using the BlephEx instrument.
Arm Title
Manual debridement
Arm Type
Experimental
Arm Description
The subjects who are enrolled in this arm will undergo manual lid margin debridement using a stainless steel ophthalmic golf spud.
Intervention Type
Device
Intervention Name(s)
BlephEx
Intervention Description
Electronic lid margin debridement
Intervention Type
Device
Intervention Name(s)
Manual debridement
Intervention Description
Manual lid margin debridement
Primary Outcome Measure Information:
Title
Symptomatic relief
Description
Betterment of symptoms (improvement in contact lens discomfort) will be measured using two different surveys - Ocular Surface Disease Index (OSID) and Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8). The OSDI scores can range from 0 to 100. The CLDEQ-8 scores can range from 0 to 37. In both the questionnaires, a lowering of the score during follow-up visits represents a betterment of symptoms suffered by the patient. The numerical change in the scores on these two questionnaires will be documented as the change in symptom profile of the patient (betterment / worsening / stability).
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Meibography
Description
Meibomian gland imaging will be performed to document any changes in the Meibomian gland during the study period.
Time Frame
60 days
Title
Lissamine green staining grade of the lid margin
Description
The lid margin will be stained with Lissamine green dye. For the purpose of this study, Lissamine green staining of the eyelid margins will be graded from 0 to 4. (Zero representing "normal" or "no" staining; Four representing the highest degree of staining). During the course of the study, a decrease in lid margin staining will indicate a betterment of the health of the eyelid margin.
Time Frame
60 days
Title
Inflammatory activity
Description
The presence or absence of Matrix Metalloproteinase-9 (MMP-9) in the tear fluid will be documented during the study visits. Presence of MMP-9 in the tear fluid indicates the presence of inflammatory activity in the tear fluid.
Time Frame
60 days
Title
Tear break-up time
Description
Improvement in non-invasive tear break-up time measurement will be an objective outcome of the study.
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Habitual contact lens wearers whose contact lens wear time has reduced due to MGD will be preferentially considered for this study. Subjects who currently cannot wear contact lenses due to MGD may be considered on a case-by-case basis.
Exclusion Criteria:
Subjects who are currently using any prescription ophthalmic medications (such as antibiotics, steroids and immunomodulatory drugs) will be excluded from participation.
Subjects who have active ocular infections will be excluded from participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srihari Narayanan, OD, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rosenberg School of Optometry
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD.
Citations:
PubMed Identifier
24145633
Citation
Korb DR, Blackie CA. Debridement-scaling: a new procedure that increases Meibomian gland function and reduces dry eye symptoms. Cornea. 2013 Dec;32(12):1554-7. doi: 10.1097/ICO.0b013e3182a73843.
Results Reference
result
Learn more about this trial
Meibomian Gland Dysfunction Management
We'll reach out to this number within 24 hrs