Clinical Trial: Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.

Sponsor: University of the Incarnate Word

Current Primary Outcome: Ocular irritation symptoms (OSDI Questionnaire score) [ Time Frame: one month ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Tear break-up [ Time Frame: one month ]

Original Secondary Outcome: Same as current

Information By: University of the Incarnate Word

Dates:
Date Received: October 29, 2016
Date Started: May 2015
Date Completion: October 2017
Last Updated: November 1, 2016
Last Verified: November 2016