Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis

Sponsor

University of the Incarnate Word (Other)

Overall Status

Completed

CT.gov ID

NCT02952079

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meibomian Gland Dysfunction Dry Eye Posterior Blepharitis	Device: Blephex Device: MiboFlo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis

Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: BlephEx treatment Treatment with the BlephEx instrument (lid margin exfoliation)	Device: Blephex Lid margin exfoliation
Active Comparator: MiBoFlo treatment Treatment with the MiboFlo equipment (heat therapy to eyelids)	Device: MiboFlo Lid warming treatment

Arm

Intervention/Treatment

Active Comparator: BlephEx treatment

Treatment with the BlephEx instrument (lid margin exfoliation)

Device: Blephex

Lid margin exfoliation

Active Comparator: MiBoFlo treatment

Treatment with the MiboFlo equipment (heat therapy to eyelids)

Device: MiboFlo

Lid warming treatment

Outcome Measures

Primary Outcome Measures

Ocular irritation symptoms (OSDI Questionnaire score) [one month]

Secondary Outcome Measures

Tear break-up [one month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rosenberg School of Optometry	San Antonio	Texas	United States	78229

Sponsors and Collaborators

University of the Incarnate Word

Investigators

Principal Investigator: Srihari Narayanan, OD, PhD, University of the Incarnate Word

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SRIHARI NARAYANAN, Professor, University of the Incarnate Word

ClinicalTrials.gov Identifier:

NCT02952079

Other Study ID Numbers:

15-06-015

First Posted:

Nov 2, 2016

Last Update Posted:

Jun 8, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Meibomian Gland Dysfunction

Blepharitis

Study Results

No Results Posted as of Jun 8, 2018