Characterization of Signs and Symptoms of Participants With and Without Meibomian Gland Dysfunction

Completed

• Conditions: Meibomian Glands
• Interventions: Procedure: Meibum Expression

• Registration Number: NCT01979887
• Lead Sponsor: Allergan

Brief Summary

This is an exploratory study to evaluate endpoints used to characterize participants with and without meibomian gland dysfunction (MGD) and will evaluate the correlation between signs and symptoms of MGD. No investigational drug will be administered in this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-08
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-14
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

-Participants characterized as with or without Meibomian Gland Dysfunction.

Exclusion Criteria

• Lid heating therapy, therapeutic gland expression, or meibomian gland probing within 12 months of enrollment
• Contact lens use in the 30 days prior to enrollment
• Lid hygiene within 48 hours prior to enrollment
• Use of eye makeup within 8 hours of enrollment
• Eyelash growth-stimulating products within 30 days prior to enrollment
• Use of systemic vitamins and/or systemic supplements containing omega 3 fatty acids within 60 days of enrollment
• Use of systemic anti-histamines within 30 days prior to enrollment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-MGD Participants	Meibum Expression	Participants without MGD who have meibum expressed as per protocol. No investigational drug is administered in this study.
Mild-Moderate MGD Participants	Meibum Expression	Participants with Mild-Moderate MGD who have meibum expressed as per protocol. No investigational drug is administered in this study.
Severe MGD Participants	Meibum Expression	Participants with Severe MGD who have meibum expressed as per protocol. No investigational drug is administered in this study.

Primary Outcome Measures

Name	Time	Method
Meibum Quality Score in the Study Eye as Assessed by the Investigator Using a 4-Point Scale	Day 22