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CompletedNCT02952079Updated Jun 8, 2018

Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis

An interventional study of Blephex and MiboFlo in Meibomian Gland Dysfunction, Dry Eye and Posterior Blepharitis, sponsored by University of the Incarnate Word. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-08.

Sponsored by University of the Incarnate Word · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 63 studies in Meibomian Gland Dysfunction with a site in United States — 7 open to participants now, 10 under way, none of them phase 3. Meibomian Gland Dysfunction · United States.

Enrollment
56th of 61
11 · median 44
Started
2015
with 2 others
No phase
42 of 63
4 open now
Registered
17th of 63
by date
Lead sponsor
4 of 63
University of the Incarnate Word

Among the 63 studies in Meibomian Gland Dysfunction with a site in United States, this one is the 56th largest by enrollment of the 61 interventional ones that give a count, is one of 3 that started in 2015, is one of 42 with no phase, and was the 17th registered.

Meibomian Gland Dysfunction

172 studies on the registry are indexed under Meibomian Gland Dysfunction; 23 are open to participants now.

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Open to participants now

7 of the 63 studies in Meibomian Gland Dysfunction with a site in United States are open now. Recruiting first, the newest first:

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All 7 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 13 Meibomian Gland Dysfunction studies recruiting now, 10 (77%) set no upper age limit and 1 (8%) stop at 75 or younger; 1 take children under 18; 1 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Meibomian Gland Dysfunction
  • Dry Eye
  • Posterior Blepharitis
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must have dry eye secondary to Meibomian gland dysfunction (posterior blepharitis)

Exclusion criteria

Exclusion Criteria:

  • Must not have active ocular surface infections. Must not be currently using or eye drops.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Active comparator
    BlephEx treatment

    Treatment with the BlephEx instrument (lid margin exfoliation)

    Device: Blephex

  • Active comparator
    MiBoFlo treatment

    Treatment with the MiboFlo equipment (heat therapy to eyelids)

    Device: MiboFlo

Interventions

  • DeviceBlephex

    Lid margin exfoliation

  • DeviceMiboFlo

    Lid warming treatment

06

What researchers measure

Primary outcomes

  1. Ocular irritation symptoms (OSDI Questionnaire score)

    Time frame: one month

Secondary outcomes

  1. Tear break-up

    Time frame: one month

07

Study locations

1 site
  • Rosenberg School of Optometry
    San Antonio, Texas 78229, United States
08

References and documents

Individual participant data

Plan to share: No — No plan to share IPD to other researchers

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2015, a primary completion of Apr 2018 and a completion of Apr 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2016
First posted
Nov 2, 2016
Start
May 2015
Primary completionActual
Apr 2018
CompletionActual
Apr 2018
Last update
Jun 8, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02952079
Lead sponsor
University of the Incarnate Word
Responsible party
SRIHARI NARAYANAN (Professor, University of the Incarnate Word) — Principal investigator
First posted
Nov 2, 2016
Start date
May 2015
Primary completion
Apr 2018
Completion
Apr 2018
Last update
Jun 8, 2018

Study contacts

Srihari Narayanan, OD, PhD
principal investigator · University of the Incarnate Word

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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