Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis
Primary Purpose
Meibomian Gland Dysfunction, Dry Eye, Posterior Blepharitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blephex
MiboFlo
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Must have dry eye secondary to Meibomian gland dysfunction (posterior blepharitis)
Exclusion Criteria:
- Must not have active ocular surface infections. Must not be currently using steroids or immunosuppression eye drops.
Sites / Locations
- Rosenberg School of Optometry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
BlephEx treatment
MiBoFlo treatment
Arm Description
Treatment with the BlephEx instrument (lid margin exfoliation)
Treatment with the MiboFlo equipment (heat therapy to eyelids)
Outcomes
Primary Outcome Measures
Ocular irritation symptoms (OSDI Questionnaire score)
Secondary Outcome Measures
Tear break-up
Full Information
NCT ID
NCT02952079
First Posted
October 29, 2016
Last Updated
June 6, 2018
Sponsor
University of the Incarnate Word
1. Study Identification
Unique Protocol Identification Number
NCT02952079
Brief Title
Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis
Official Title
Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Incarnate Word
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to compare which treatment - BlephEx or MiBoFlo - will be a better option for patients suffering from dry eye secondary to Meibomian Gland dysfunction.
Detailed Description
The investigators have previously studied the effect of the BlephEx instrument (debridement of lid debris) in relieving signs and symptoms of blepharitis (Connor CG et al, ARVO 2014). This previous study demonstrated positive results from the BlephEx treatment. Warming the eyelids (e.g., using warm wash cloths) still remains a viable treatment option for this disease. However, patients are often non-compliant with warm compress therapy due to the requirement of performing it at least twice per day. The MiBoflo delivers uniform and consistent amounts of heat to the eyelid. It is suggested that two treatments over 30 days is adequate to relieve signs and symptoms of Meibomian gland dysfunction. This equipment is currently used in optometric practices in this country.
There are no clinical studies comparing BlephEx and MiBoflo as treatment options for blepharitis. Hence, the current study will provide new and useful information on which treatment option may be better for treating blepharitis and Meibomian gland dysfunction. Part of this study will also investigate if a combination of BlephEx and MiBoflo treatments is more beneficial to the patient. The data generated will directly benefit clinical practice and impact several millions of patients who suffer from this Blepharitis and / or Meibomian gland dysfunction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction, Dry Eye, Posterior Blepharitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BlephEx treatment
Arm Type
Active Comparator
Arm Description
Treatment with the BlephEx instrument (lid margin exfoliation)
Arm Title
MiBoFlo treatment
Arm Type
Active Comparator
Arm Description
Treatment with the MiboFlo equipment (heat therapy to eyelids)
Intervention Type
Device
Intervention Name(s)
Blephex
Intervention Description
Lid margin exfoliation
Intervention Type
Device
Intervention Name(s)
MiboFlo
Intervention Description
Lid warming treatment
Primary Outcome Measure Information:
Title
Ocular irritation symptoms (OSDI Questionnaire score)
Time Frame
one month
Secondary Outcome Measure Information:
Title
Tear break-up
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have dry eye secondary to Meibomian gland dysfunction (posterior blepharitis)
Exclusion Criteria:
Must not have active ocular surface infections. Must not be currently using steroids or immunosuppression eye drops.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srihari Narayanan, OD, PhD
Organizational Affiliation
University of the Incarnate Word
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
No plan to share IPD to other researchers
Learn more about this trial
Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis
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