Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis

NCT ID: NCT02952079

Last Updated: 2018-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-04-30

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.

Conditions

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Meibomian Gland Dysfunction Dry Eye Posterior Blepharitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BlephEx treatment

Treatment with the BlephEx instrument (lid margin exfoliation)

Group Type ACTIVE_COMPARATOR

Blephex

Intervention Type DEVICE

Lid margin exfoliation

MiBoFlo treatment

Treatment with the MiboFlo equipment (heat therapy to eyelids)

Group Type ACTIVE_COMPARATOR

MiboFlo

Intervention Type DEVICE

Lid warming treatment

Interventions

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Blephex

Lid margin exfoliation

Intervention Type DEVICE

MiboFlo

Lid warming treatment

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of the Incarnate Word

OTHER

Sponsor Role lead

Responsible Party

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SRIHARI NARAYANAN

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Srihari Narayanan, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of the Incarnate Word

Locations

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Rosenberg School of Optometry

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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15-06-015

Identifier Type: -

Identifier Source: org_study_id

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