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Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis

Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02952079
Enrollment
11
Registered
2016-11-02
Start date
2015-05-31
Completion date
2018-04-30
Last updated
2018-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye, Meibomian Gland Dysfunction, Posterior 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 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.

Interventions

DEVICEBlephex

Lid margin exfoliation

DEVICEMiboFlo

Lid warming treatment

Sponsors

University of the Incarnate Word
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Ocular irritation symptoms (OSDI Questionnaire score)one month

Secondary

MeasureTime frame
Tear break-upone month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026