Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis

Not Applicable

Completed

• Conditions: Meibomian Gland Dysfunction; Dry Eye; Posterior Blepharitis
• Interventions: Device: Blephex; Device: MiboFlo

• Registration Number: NCT02952079
• Lead Sponsor: University of the Incarnate Word

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-10-29
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-02
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-06
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BlephEx treatment	Blephex	Treatment with the BlephEx instrument (lid margin exfoliation)
MiBoFlo treatment	MiboFlo	Treatment with the MiboFlo equipment (heat therapy to eyelids)

Primary Outcome Measures

Name	Time	Method
Ocular irritation symptoms (OSDI Questionnaire score)	one month

Secondary Outcome Measures

Name	Time	Method
Tear break-up	one month

Trial Locations

Locations (1)

Rosenberg School of Optometry; 🇺🇸 San Antonio, Texas, United States