Meibomian Gland Dysfunction Management

Not Applicable

Active, not recruiting

• Conditions: Meibomian Gland Dysfunction; Contact Lens Discomfort
• Interventions: Device: Manual debridement; Device: BlephEx

• Registration Number: NCT03652337
• Lead Sponsor: University of the Incarnate Word

Brief Summary

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

Not available

Study Timeline

• Study Start: 2018-05-10
• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-08-27
• Study First Posted: 2018-08-29
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-05
• Primary Completion: 2018-12-01
• Study Completion: 2019-04-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual debridement	Manual debridement	The subjects who are enrolled in this arm will undergo manual lid margin debridement using a stainless steel ophthalmic golf spud.
BlephEx	BlephEx	The subjects who are enrolled in this arm will undergo electronic lid margin debridement using the BlephEx instrument.

Primary Outcome Measures

Name	Time	Method
Symptomatic relief	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 Outcome Measures

Name	Time	Method
Tear break-up time	60 days	Improvement in non-invasive tear break-up time measurement will be an objective outcome of the study.
Meibography	60 days	Meibomian gland imaging will be performed to document any changes in the Meibomian gland during the study period.
Lissamine green staining grade of the lid margin	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.
Inflammatory activity	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.

Trial Locations

Locations (1)

Rosenberg School of Optometry; 🇺🇸 San Antonio, Texas, United States