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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01979887
• Collaborator: (none)
• Enrollment: 75
• Locations: 2
• Duration (Months): 8
• Patients Per Site: 37.5
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meibomian Glands	Procedure: Meibum Expression

Study Design

• Study Type: Observational
• Actual Enrollment: 75 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Non-MGD Participants Participants without MGD who have meibum expressed as per protocol. No investigational drug is administered in this study.	Procedure: Meibum Expression; Meibum expression as per protocol. No investigational drug is administered in this study.
Mild-Moderate MGD Participants Participants with Mild-Moderate MGD who have meibum expressed as per protocol. No investigational drug is administered in this study.	Procedure: Meibum Expression; Meibum expression as per protocol. No investigational drug is administered in this study.
Severe MGD Participants Participants with Severe MGD who have meibum expressed as per protocol. No investigational drug is administered in this study.	Procedure: Meibum Expression; Meibum expression as per protocol. No investigational drug is administered in this study.

Outcome Measures

Primary Outcome Measures

1. Meibum Quality Score in the Study Eye as Assessed by the Investigator Using a 4-Point Scale [Day 22]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Houston	Texas	United States
2		London		United Kingdom

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01979887
• Other Study ID Numbers: 195263-007
• First Posted: Nov 8, 2013
• Last Update Posted: Aug 15, 2014
• Last Verified: Aug 1, 2014

Study Results

No Results Posted as of Aug 15, 2014