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

August 14, 2014 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants characterized as with or without Meibomian Gland Dysfunction.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Meibum Quality Score in the Study Eye as Assessed by the Investigator Using a 4-Point Scale
Time Frame: Day 22
Day 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

November 4, 2013

First Submitted That Met QC Criteria

November 7, 2013

First Posted (Estimate)

November 8, 2013

Study Record Updates

Last Update Posted (Estimate)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 14, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 195263-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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