Meibomian Gland Dysfunction Management

Study Overview
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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.

Official Title
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Meibomian Gland Dysfunction Management to Relieve Contact Lens Discomfort

Conditions
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Contact Lens Discomfort, Meibomian Gland Dysfunction

Intervention / Treatment
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* Device: BlephEx
* Device: Manual debridement


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BlephEx<br>The subjects who are enrolled in this arm will undergo electronic lid margin debridement using the BlephEx instrument. | Device: BlephEx<br>* Electronic lid margin debridement<br>|
| Experimental: Manual debridement<br>The subjects who are enrolled in this arm will undergo manual lid margin debridement using a stainless steel ophthalmic golf spud. | Device: Manual debridement<br>* Manual lid margin debridement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic relief | 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). | 60 days | 

Secondary Outcome Measures

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