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

NCT01979887 | Completed

• 1 other identifier: 195263-007
• Study Type: observational
• Target: 75
• Locations: 2 countries
• Sites: 2

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.

Conditions

Meibomian Glands

Outcome Measures

Primary Outcomes (1)

• Meibum Quality Score in the Study Eye as Assessed by the Investigator Using a 4-Point Scale

  Day 22

Study Arms (3)

Non-MGD Participants

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

Procedure: Meibum Expression

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

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

Interventions

Meibum Expression PROCEDURE

Meibum expression as per protocol. No investigational drug is administered in this study.

Mild-Moderate MGD Participants; Non-MGD Participants; Severe MGD Participants

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants characterized as with or without Meibomian Gland Dysfunction.

You may qualify if:

• Participants characterized as with or without Meibomian Gland Dysfunction.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (3)

• Ajouz L, Hallak J, Naik R, Nguyen A, Zhao C, Robinson MR, Nichols KK. Evaluation of the Impact of Meibomian Gland Dysfunction Using a Novel Patient-Reported Outcome Instrument. J Ocul Pharmacol Ther. 2024 Jan-Feb;40(1):48-56. doi: 10.1089/jop.2023.0080. Epub 2023 Nov 1.

  PMID: 37910805 DERIVED

• Ajouz L, Nguyen A, Zhao C, Robinson MR, Nichols KK. Exploring Signs and Symptoms Associated with Meibomian Gland Dysfunction for Use as Clinical Trial Endpoints. J Ocul Pharmacol Ther. 2023 Nov;39(9):611-621. doi: 10.1089/jop.2023.0064. Epub 2023 Aug 29.

  PMID: 37643299 DERIVED

• Nagar S, Ajouz L, Nichols KK, Kumar S, Zhao C, Naidoo KK, Robinson MR, Borchman D. Relationship Between Human Meibum Lipid Composition and the Severity of Meibomian Gland Dysfunction: A Spectroscopic Analysis. Invest Ophthalmol Vis Sci. 2023 Jul 3;64(10):22. doi: 10.1167/iovs.64.10.22.

  PMID: 37466951 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tears

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 8, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

US (1); GB (1)