Meibomian Gland Dysfunction Management

Meibomian Gland Dysfunction Clinical Trial

Official title:

Meibomian Gland Dysfunction Management to Relieve Contact Lens Discomfort

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03652337
• Other study ID #: 18-04-003
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 10, 2018
• Est. completion date: April 10, 2019

Study information

• Verified date: September 2018
• Source: University of the Incarnate Word
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 10, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Contact Lens Discomfort
• Meibomian Gland Dysfunction

Intervention

Device:
• BlephEx
Electronic lid margin debridement
• Manual debridement
Manual lid margin debridement

Locations

Country	Name	City	State
United States	Rosenberg School of Optometry	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of the Incarnate Word	American Academy of Optometry

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Meibography	Meibomian gland imaging will be performed to document any changes in the Meibomian gland during the study period.	60 days
Secondary	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
Secondary	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
Secondary	Tear break-up time	Improvement in non-invasive tear break-up time measurement will be an objective outcome of the study.	60 days