Meibomian Gland DysfunctionNCT02952079
Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis
A study testing Blephex and MiboFlo in people with Meibomian Gland Dysfunction and Dry Eye, run by University of the Incarnate Word at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction, Dry Eye, Posterior Blepharitis
- What is being tested?
- Blephex and MiboFlo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have dry eye secondary to Meibomian gland dysfunction (posterior blepharitis)
Who cannot join
- Must not have active ocular surface infections. Must not be currently using steroids or immunosuppression eye drops.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rosenberg School of Optometry
San Antonio, Texas, 78229
About this study
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.
- Conditions
- Meibomian Gland Dysfunction, Dry Eye, Posterior Blepharitis
- Being tested
- Blephex, MiboFlo
- Medical subject headings
- Meibomian Gland Dysfunction, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlephexDevice
Lid margin exfoliation
MiboFloDevice
Lid warming treatment
| Study group | Role | What they receive |
|---|---|---|
| BlephEx treatment | Active comparator | Treatment with the BlephEx instrument (lid margin exfoliation) Receives: Device: Blephex |
| MiBoFlo treatment | Active comparator | Treatment with the MiboFlo equipment (heat therapy to eyelids) Receives: Device: MiboFlo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular irritation symptoms (OSDI Questionnaire score)
Measured: one month
Secondary outcomes (1)
Tear break-up
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startMay 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Incarnate Word
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SRIHARI NARAYANAN, University of the Incarnate Word
- Investigators
- Srihari Narayanan, OD, PhD, Principal investigator, University of the Incarnate Word
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952079
- Sponsor's protocol ID
- 15-06-015
- Status last verified
- Jun 2018
- First submitted
- 29 Oct 2016
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share IPD to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis
- ClinicalTrials.gov ID
- NCT02952079
- Acronym / sponsor ID
- 15-06-015
- Conditions
- Meibomian Gland Dysfunction, Dry Eye, Posterior Blepharitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of the Incarnate WordUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BlephEx treatment | Active comparator | Device: BlephexTreatment with the BlephEx instrument (lid margin exfoliation) |
| MiBoFlo treatment | Active comparator | Device: MiboFloTreatment with the MiboFlo equipment (heat therapy to eyelids) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must have dry eye secondary to Meibomian gland dysfunction (posterior blepharitis)
Key exclusion criteria (1 listed)
- Must not have active ocular surface infections. Must not be currently using steroids or immunosuppression eye drops.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlephexLid margin exfoliation | Device | BlephEx treatment |
| MiboFloLid warming treatment | Device | MiBoFlo treatment |
Primary outcome
Ocular irritation symptoms (OSDI Questionnaire score)
Time frame: one month
1 secondary outcome
Tear break-up
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Individual participant dataSharing planned: No. No plan to share IPD to other researchers
Related trials for Meibomian Gland Dysfunction
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Meibomian Gland Dysfunction (Disorder)
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Autologous Serum Obtained by a Closed-Circuit Collection Device
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Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
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Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srihari Narayanan, OD, PhD principal investigator
University of the Incarnate Word
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blephex and MiboFlo in people with Meibomian Gland Dysfunction and Dry Eye, run by University of the Incarnate Word at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular irritation symptoms (OSDI Questionnaire score) (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2018.