Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface (EML-MSO)

April 18, 2024 updated by: Centre hospitalier de l'Université de Montréal (CHUM)
This study aims to obtain the lacrimal fingerprint for frequent pathologies of the ocular surface and establish a normative base for each of them.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an exploratory study. The investigators aim to:

  • Test and perfect a tear sample analysis technique by mass spectrometry with samples collected by Schirmer strips;
  • Obtain the lacrimal fingerprint for various pathologies of the ocular surface, notably different forms of dry eye syndrome, infectious keratitis/conjunctivitis, mucous membrane pemphigoid and allergic conjunctivitis, and establish a normative base for each of them.

During regular clinics at the cornea service of the ophthalmology department of the CHUM (Centre Hospitalier de l'Université de Montréal), the investigators aim to recruit a few hundred patients with various pathologies of the ocular surface, notably different forms of dry eye syndrome, infectious keratitis/conjunctivitis, mucous membrane pemphigoid and allergic conjunctivitis, and collect a sample of their tears via Schirmer strip. A case report form will be completed for each patient, noting known ocular diagnoses and active topical ophthalmic medication. Schirmer strips will be sent in sterile tubes to UQAM (Université du Québec à Montréal)'s department of chemistry for analysis by mass spectrometry.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
      • Montreal, Quebec, Canada, H2X 2J6
        • Active, not recruiting
        • Université du Québec à Montréal (UQAM) - Department of Chemistry

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients consulting at the cornea service of the ophthalmology department of the CHUM.

Description

Inclusion Criteria:

  • Patients with healthy corneas or suffering from one of these pathologies:

Dry eye syndrome; Infectious keratitis and/or conjunctivitis; Mucous membrane pemphigoid; Allergic conjunctivitis.

Exclusion Criteria:

  • Patients younger than 18 years old;
  • Patients incapable of giving informed consent.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Healthy, normal ocular surface
Diagnostic test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry
During regular consultations at the ophthalmology department of the CHUM, eligible patients will undergo a standard 5 minute Schirmer tear test. The Schirmer strips will serve as tear samples and will be sent to UQAM's Department of chemistry for mass spectrometry analysis.
Dry eye syndrome

Patients suffering from either:

  • Lacrimal insufficiency
  • Anterior blepharitis
  • Posterior blepharitis
  • Sjögren syndrome
Diagnostic test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry
During regular consultations at the ophthalmology department of the CHUM, eligible patients will undergo a standard 5 minute Schirmer tear test. The Schirmer strips will serve as tear samples and will be sent to UQAM's Department of chemistry for mass spectrometry analysis.
Allergic conjunctivitis
Patients suffering from allergic conjunctivitis
Diagnostic test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry
During regular consultations at the ophthalmology department of the CHUM, eligible patients will undergo a standard 5 minute Schirmer tear test. The Schirmer strips will serve as tear samples and will be sent to UQAM's Department of chemistry for mass spectrometry analysis.
Mucous membrane pemphigoid
Patients suffering from mucous membrane pemphigoid
Diagnostic test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry
During regular consultations at the ophthalmology department of the CHUM, eligible patients will undergo a standard 5 minute Schirmer tear test. The Schirmer strips will serve as tear samples and will be sent to UQAM's Department of chemistry for mass spectrometry analysis.
Infectious keratoconjunctivitis

Patients suffering from keratitis and/or conjunctivitis of various etiology:

  • Viral
  • Bacterial
  • Fungal
  • Acanthamoeba
Diagnostic test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry
During regular consultations at the ophthalmology department of the CHUM, eligible patients will undergo a standard 5 minute Schirmer tear test. The Schirmer strips will serve as tear samples and will be sent to UQAM's Department of chemistry for mass spectrometry analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To obtain the metabolomic and proteomic fingerprint of the studied ocular surface pathologies
Time Frame: 5 years
Raw data will be analysed with MarkerView software by Sciex to identify specific over- or under-expressed markers in these ocular pathologies.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To objectify changes in metabolomic and proteomic profile associated with topical treatments taken by participants in this study
Time Frame: 5 years
Raw data will be analysed with the same software to identify specific changes in proteomic and/or metabolomic expression associated with the topical treatments taken by participants in this study.
5 years

Collaborators and Investigators

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

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Université du Québec a Montréal

Investigators

  • Principal Investigator: Marie-Claude Robert, MD, M.Sc, Centre Hospitalier de l'Université de Montréal (CHUM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 1, 2020

Primary Completion (Estimated)

October 1, 2034

Study Completion (Estimated)

January 1, 2035

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (Actual)

December 13, 2019

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE19.212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators do not plan to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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