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Completed

NCT Number: NCT02952079

Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis

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.

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Key information

Conditions

Meibomian Gland Dysfunction Dry Eye Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Posterior Blepharitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rosenberg School of Optometry

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BlephEx

Device

Lid margin exfoliation

MiboFlo

Device

Lid warming treatment

Primary outcomes

  1. Ocular irritation symptoms (OSDI Questionnaire score)

    Time frame: one month

Secondary outcomes

  1. Tear break-up

    Time frame: one month

Sponsors and collaborators

Lead sponsor

University of the Incarnate Word

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 2, 2016
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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