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

Meibomian Glands Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01979887
• Other study ID #: 195263-007
• Status: Completed
• Phase: N/A
• First received: November 4, 2013
• Last updated: August 14, 2014
• Start date: November 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Meibomian Glands

Intervention

Procedure:
• Meibum Expression
Meibum expression as per protocol. No investigational drug is administered in this study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meibum Quality Score in the Study Eye as Assessed by the Investigator Using a 4-Point Scale		Day 22	No