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Effect of Meibomian Gland Probing on Ocular Surface in Ocular Rosacea

Primary Purpose

Meibomian Gland Dysfunction

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
meibomian gland probing
Left eye Meibomian Gland Probing Control Group
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Diagnosed Ocular Rosacea +/- Facial Rosacea

Exclusion Criteria:

  • 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

Sites / Locations

  • Jones Eye Institute, UAMS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probing Treatment Right Eye

Fellow Eye (Left) Untreated

Arm Description

Meibomian gland will be performed on the right upper eye lid of each participant.

The fellow eye (left) will be used at the untreated control

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2016
Last Updated
April 24, 2018
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT02735681
Brief Title
Effect of Meibomian Gland Probing on Ocular Surface in Ocular Rosacea
Official Title
Effect of Meibomian Gland Probing on Ocular Surface in Ocular Rosacea
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Trouble recruiting
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
March 28, 2018 (Actual)
Study Completion Date
March 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Meibomian gland probing is a relatively new, safe, and effective technique for treating obstructive meibomian gland dysfunction (o-MGD). It involves topical anesthesia of the eyelid margins and insertion of a 2 mm or 4 mm sterile, beveled, solid stainless steel probe at the slit lamp. Meibomian gland probing has been reported to alleviate symptoms (lid tenderness / lid margin congestion) of o-MGD (Maskin, 2010). It has also been shown to improve meibum lipid levels, viscosity, and tear breakup time (Nakayama, Kawashima, Kaido, Arita, & Tsubota, 2015). Though probing has been investigated in a few small studies of o-MGD, only one small study of 10 participants has investigated meibomian gland probing in ocular rosacea (Wladis, 2012). This study showed improvement in ocular surface disease index (OSDI, a standardized questionnaire assessing dry eye) but did not show objective improvement by way of examination findings or analysis of meibum (Wladis, 2012). In our study, Investigators intend to further investigate meibomian gland probing in participants with diagnosed ocular rosacea. Investigators hypothesize that after probing of one eye, Investigators will note improvements in participants symptoms as reflected in improvement in OSDI scores, Reductions in Inflamma-Dry measures (measure of matrix metalloproteinase (MMP-9), an inflammatory marker elevated in tears of participants with dry eye), decreased tear fluid osmolarity, decreased meibum viscosity on expression . Objective improvement in lid margin disease (noting collarettes, pitting, telangiectasia of lid margins, thickening / irregularity of lid margins, lid margin tenderness; improvement in tear break up time (TBUT); and improvement in corneal fluorescein / lissamine green staining).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probing Treatment Right Eye
Arm Type
Active Comparator
Arm Description
Meibomian gland will be performed on the right upper eye lid of each participant.
Arm Title
Fellow Eye (Left) Untreated
Arm Type
Placebo Comparator
Arm Description
The fellow eye (left) will be used at the untreated control
Intervention Type
Procedure
Intervention Name(s)
meibomian gland probing
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Left eye Meibomian Gland Probing Control Group
Intervention Description
There will be no probing in the left eye. This will be used as a control for the right eye.
Primary Outcome Measure Information:
Title
Improvements in participants symptoms as reflected in improvement in Ocular Surface Disease Index (OSDI) scores
Description
The OSDI is assessed on a scale of 0 and 100, with higher scores representing greater disability.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Diagnosed Ocular Rosacea +/- Facial Rosacea Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunali Goyal, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joshua Hardin, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jones Eye Institute, UAMS
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Meibomian Gland Probing on Ocular Surface in Ocular Rosacea

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