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OpenTrials
Active, Not Recruiting

NCT Number: NCT03652337

Meibomian Gland Dysfunction Management

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Contact Lens Discomfort Eye Diseases Eyelid Diseases Meibomian Gland Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rosenberg School of Optometry

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BlephEx

Device

Electronic lid margin debridement

Manual debridement

Device

Manual lid margin debridement

Primary outcomes

  1. Symptomatic relief

    Time frame: 60 days

    Betterment of symptoms (improvement in contact lens discomfort) will be measured using two different surveys - Ocular Surface Disease Index (OSID) and Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8). The OSDI scores can range from 0 to 100. The CLDEQ-8 scores can range from 0 to 37. In both the questionnaires, a lowering of the score during follow-up visits represents a betterment of symptoms suffered by the patient. The numerical change in the scores on these two questionnaires will be documented as the change in symptom profile of the patient (betterment / worsening / stability).

Secondary outcomes

  1. Meibography

    Time frame: 60 days

    Meibomian gland imaging will be performed to document any changes in the Meibomian gland during the study period.

  2. Lissamine green staining grade of the lid margin

    Time frame: 60 days

    The lid margin will be stained with Lissamine green dye. For the purpose of this study, Lissamine green staining of the eyelid margins will be graded from 0 to 4. (Zero representing "normal" or "no" staining; Four representing the highest degree of staining). During the course of the study, a decrease in lid margin staining will indicate a betterment of the health of the eyelid margin.

  3. Inflammatory activity

    Time frame: 60 days

    The presence or absence of Matrix Metalloproteinase-9 (MMP-9) in the tear fluid will be documented during the study visits. Presence of MMP-9 in the tear fluid indicates the presence of inflammatory activity in the tear fluid.

  4. Tear break-up time

    Time frame: 60 days

    Improvement in non-invasive tear break-up time measurement will be an objective outcome of the study.

Sponsors and collaborators

Lead sponsor

University of the Incarnate Word

Other

Collaborators

  • American Academy of Optometry

Registry information

Official study title

Meibomian Gland Dysfunction Management to Relieve Contact Lens Discomfort

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Aug 29, 2018
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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