Meibomian Gland Dysfunction Treatment

NCT ID: NCT04229888

Last Updated: 2022-03-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-26

Study Completion Date

2021-03-25

Brief Summary

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The purpose of this study is to evaluate the effectiveness of treatments for Meibomian Gland Dysfunction.

Detailed Description

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Conditions

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Meibomian Gland Dysfunction Dry Eye

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All subjects will receive first treatment and then second treatment. The eye receiving treatment will be randomly selected. The same eye will receive both treatments.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Outcomes assessor blinded to visit schedule. Participants masked to invalidity of sham treatment.

Study Groups

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Subject Treatment

All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment.

Group Type EXPERIMENTAL

LipiFlow

Intervention Type DEVICE

Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content

Light Based (Sham) Treatment

Intervention Type DEVICE

A light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment.

Interventions

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LipiFlow

Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content

Intervention Type DEVICE

Light Based (Sham) Treatment

A light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment.

Intervention Type DEVICE

Other Intervention Names

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Johnson & Johnson

Eligibility Criteria

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Inclusion Criteria

* evidence of meibomian gland obstruction in both eyes
* dry eye symptoms per DEQ-5

Exclusion Criteria

* active ocular infection
* previous LipiFlow treatment
* beginning new oral or other systemic medications within prior 3 months
* beginning new or changing dosages of ocular medications within prior 3 months
* previous ocular surgery, trauma, herpes, recurrent inflammation, punctal plugs in prior 3 months
* habitual contact lens wear in prior 3 months
* women who are pregnant or nursing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Anna Tichenor

Assistant Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Indiana University School of Optometry

Bloomington, Indiana, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1908329543

Identifier Type: -

Identifier Source: org_study_id

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