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NCT02952079 Clinical Trial

Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02952079
Other study ID # 15-06-015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2015
Est. completion date April 2018

Study information
Verified date June 2018
Source University of the Incarnate Word
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date April 2018
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Blephex
Lid margin exfoliation
• MiboFlo
Lid warming treatment

Locations
Country Name City State
United States Rosenberg School of Optometry San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
University of the Incarnate Word

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular irritation symptoms (OSDI Questionnaire score) one month
Secondary Tear break-up one month
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