Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis

Conditions
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Dry Eye, Meibomian Gland Dysfunction, Posterior Blepharitis

Intervention / Treatment
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* Device: Blephex
* Device: MiboFlo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BlephEx treatment<br>Treatment with the BlephEx instrument (lid margin exfoliation) | Device: Blephex<br>* Lid margin exfoliation<br>|
| Active Comparator: MiBoFlo treatment<br>Treatment with the MiboFlo equipment (heat therapy to eyelids) | Device: MiboFlo<br>* Lid warming treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular irritation symptoms (OSDI Questionnaire score) |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear break-up |  | one month |