Study Stopped
Trouble recruiting
Effect of Meibomian Gland Probing on Ocular Surface in Ocular Rosacea
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Meibomian glands (MG) are modified sebaceous glands associated with the tarsus (collagenous structural component) of the upper and lower eyelids. Meibomian glands produce lipid-based secretions which are an integral and stabilizing part of the tear film. In blepharitis and ocular rosacea (two known causes of obstructive meibomian gland dysfunction (o-MGD), inflammation of the lid margins causes blockage of the meibomian gland orifices, changes in glandular secretions, and dropout of the glands themselves. This limits the production, secretion, and quality of meibum. With less oil in the tear film, the aqueous portion of tears is not stable and evaporates quickly which leads to dry eye.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2016
CompletedFirst Posted
Study publicly available on registry
April 13, 2016
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2018
CompletedApril 26, 2018
April 1, 2018
1.2 years
March 29, 2016
April 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Improvements in participants symptoms as reflected in improvement in Ocular Surface Disease Index (OSDI) scores
The OSDI is assessed on a scale of 0 and 100, with higher scores representing greater disability.
Up to 6 months
Study Arms (2)
Probing Treatment Right Eye
ACTIVE COMPARATORMeibomian gland will be performed on the right upper eye lid of each participant.
Fellow Eye (Left) Untreated
PLACEBO COMPARATORThe fellow eye (left) will be used at the untreated control
Interventions
Investigator will do baseline (OSDI) questionnaires prior to probing as well as at 1 week (at home), 1 month, 3months, and 6 months at office visits.
There will be no probing in the left eye. This will be used as a control for the right eye.
Eligibility Criteria
You may qualify if:
- Diagnosed Ocular Rosacea +/- Facial Rosacea
You may not qualify if:
- Prior meibomian gland probing
- Prior treatment with Lipiflow
- Cicatricial Disease
- Sjogren's Syndrome
- Prior radiation therapy to face / head
- Allergy to lissamine green and fluorescein
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jones Eye Institute, UAMS
Little Rock, Arkansas, 72205, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sunali Goyal, MD
University of Arkansas
- PRINCIPAL INVESTIGATOR
Joshua Hardin, MD
University of Arkansas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2016
First Posted
April 13, 2016
Study Start
February 1, 2017
Primary Completion
March 28, 2018
Study Completion
March 28, 2018
Last Updated
April 26, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share