Meibomian Gland Dysfunction Management
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2018
CompletedFirst Submitted
Initial submission to the registry
June 19, 2018
CompletedFirst Posted
Study publicly available on registry
August 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2019
CompletedSeptember 5, 2018
September 1, 2018
7 months
June 19, 2018
September 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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).
60 days
Secondary Outcomes (4)
Meibography
60 days
Lissamine green staining grade of the lid margin
60 days
Inflammatory activity
60 days
Tear break-up time
60 days
Study Arms (2)
BlephEx
EXPERIMENTALThe subjects who are enrolled in this arm will undergo electronic lid margin debridement using the BlephEx instrument.
Manual debridement
EXPERIMENTALThe subjects who are enrolled in this arm will undergo manual lid margin debridement using a stainless steel ophthalmic golf spud.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of the Incarnate Wordlead
- American Academy of Optometrycollaborator
Study Sites (1)
Rosenberg School of Optometry
San Antonio, Texas, 78229, United States
Related Publications (1)
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.
PMID: 24145633RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Srihari Narayanan, OD, PhD
Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2018
First Posted
August 29, 2018
Study Start
May 10, 2018
Primary Completion
December 1, 2018
Study Completion
April 10, 2019
Last Updated
September 5, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share
There is no plan to share IPD.