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

Allergan

Status: Completed

Conditions: Meibomian Glands

Treatments: Procedure: Meibum Expression

Study type: Observational

Funder types: Industry

Identifiers

NCT01979887

195263-007

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

75 participants in 3 patient groups

Non-MGD Participants

Description:

Participants without MGD who have meibum expressed as per protocol. No investigational drug is administered in this study.

Treatment:

Procedure: Meibum Expression

Mild-Moderate MGD Participants

Description:

Participants with Mild-Moderate MGD who have meibum expressed as per protocol. No investigational drug is administered in this study.

Treatment:

Procedure: Meibum Expression

Severe MGD Participants

Description:

Participants with Severe MGD who have meibum expressed as per protocol. No investigational drug is administered in this study.

Treatment:

Procedure: Meibum Expression