Meibomian Gland Dysfunction Management

NCT ID: NCT03652337

Last Updated: 2018-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-10

Study Completion Date

2019-04-10

Brief Summary

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The purpose of this study is to compare electronic debridement of the eyelid margin (BlephEx) to manual debridement of the eyelid margin as treatment options for patients intolerant to contact lens wear consequent to Meibomian gland dysfunction.

Detailed Description

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Conditions

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Contact Lens Discomfort Meibomian Gland Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BlephEx

The subjects who are enrolled in this arm will undergo electronic lid margin debridement using the BlephEx instrument.

Group Type EXPERIMENTAL

BlephEx

Intervention Type DEVICE

Electronic lid margin debridement

Manual debridement

The subjects who are enrolled in this arm will undergo manual lid margin debridement using a stainless steel ophthalmic golf spud.

Group Type EXPERIMENTAL

Manual debridement

Intervention Type DEVICE

Manual lid margin debridement

Interventions

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BlephEx

Electronic lid margin debridement

Intervention Type DEVICE

Manual debridement

Manual lid margin debridement

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Habitual contact lens wearers whose contact lens wear time has reduced due to MGD will be preferentially considered for this study. Subjects who currently cannot wear contact lenses due to MGD may be considered on a case-by-case basis.

Exclusion Criteria

* Subjects who are currently using any prescription ophthalmic medications (such as antibiotics, steroids and immunomodulatory drugs) will be excluded from participation.
* Subjects who have active ocular infections will be excluded from participation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Academy of Optometry

OTHER

Sponsor Role collaborator

University of the Incarnate Word

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Srihari Narayanan, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Rosenberg School of Optometry

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Korb DR, Blackie CA. Debridement-scaling: a new procedure that increases Meibomian gland function and reduces dry eye symptoms. Cornea. 2013 Dec;32(12):1554-7. doi: 10.1097/ICO.0b013e3182a73843.

Reference Type RESULT
PMID: 24145633 (View on PubMed)

Other Identifiers

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18-04-003

Identifier Type: -

Identifier Source: org_study_id

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