NCT02952079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

June 8, 2018

Status Verified

June 1, 2018

Enrollment Period

2.9 years

First QC Date

October 29, 2016

Last Update Submit

June 6, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ocular irritation symptoms (OSDI Questionnaire score)

    one month

Secondary Outcomes (1)

  • Tear break-up

    one month

Study Arms (2)

BlephEx treatment

ACTIVE COMPARATOR

Treatment with the BlephEx instrument (lid margin exfoliation)

Device: Blephex

MiBoFlo treatment

ACTIVE COMPARATOR

Treatment with the MiboFlo equipment (heat therapy to eyelids)

Device: MiboFlo

Interventions

BlephexDEVICE

Lid margin exfoliation

BlephEx treatment
MiboFloDEVICE

Lid warming treatment

MiBoFlo treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Must not have active ocular surface infections. Must not be currently using steroids or immunosuppression eye drops.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rosenberg School of Optometry

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Meibomian Gland DysfunctionDry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye DiseasesLacrimal Apparatus Diseases

Study Officials

  • Srihari Narayanan, OD, PhD

    University of the Incarnate Word

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 29, 2016

First Posted

November 2, 2016

Study Start

May 1, 2015

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

June 8, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

No plan to share IPD to other researchers

Locations