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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04198740
Recruitment Status : Not yet recruiting
First Posted : December 13, 2019
Last Update Posted : December 13, 2019
Sponsor:
Collaborator:
Université du Québec a Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:
This study aims to obtain the lacrimal fingerprint for frequent pathologies of the ocular surface and establish a normative base for each of them.

Condition or disease Intervention/treatment
Dry Eye Syndrome Infectious Keratoconjunctivitis Mucous Membrane Pemphigoid Allergic Conjunctivitis Diagnostic Test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients consulting at the cornea service of the ophthalmology department of the CHUM.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04198740


Contacts
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Contact: Marie-Claude Robert, MD, M.Sc 514-890-8278 marie-claude.robert.2@umontreal.ca
Contact: Marie-Catherine Tessier 514-890-8000 ext 11550 marie-catherine.tessier.chum@ssss.gouv.qc.ca

Locations
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Canada, Quebec
Université du Québec à Montréal (UQAM) - Department of Chemistry
Montreal, Quebec, Canada, H2X 2J6
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 3E4
Contact: Marie-Claude Robert, MD, M.Sc    514-890-8278    marie-claude.robert.2@umontreal.ca   
Contact: Marie-Catherine Tessier    514-890-8000 ext 11550    marie-catherine.tessier.chum@ssss.gouv.qc.ca   
Principal Investigator: Marie-Claude Robert, MD, M.Sc         
Sub-Investigator: Simon Trottier         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Université du Québec a Montréal
Investigators
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Principal Investigator: Marie-Claude Robert, MD, M.Sc Centre hospitalier de l'Université de Montréal (CHUM)

Publications:

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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04198740    
Other Study ID Numbers: CE19.212
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators do not plan to share individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Lacrimal fingerprint
Metabolomics
Proteomics
Ocular surface
Additional relevant MeSH terms:
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Pemphigoid, Benign Mucous Membrane
Pemphigoid, Bullous
Keratoconjunctivitis, Infectious
Conjunctivitis
Dry Eye Syndromes
Conjunctivitis, Allergic
Keratoconjunctivitis
Infection
Conjunctival Diseases
Eye Diseases
Lacrimal Apparatus Diseases
Keratitis
Corneal Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections