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

NCT ID: NCT01979887

Last Updated: 2014-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Meibomian Glands

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-MGD Participants

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

Meibum Expression

Intervention Type PROCEDURE

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.

Meibum Expression

Intervention Type PROCEDURE

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.

Meibum Expression

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Meibum Expression

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Houston, Texas, United States

Site Status

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37910805 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37643299 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37466951 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

195263-007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.