Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface

Recruiting

• Conditions: Allergic Conjunctivitis; Dry Eye Syndrome; Mucous Membrane Pemphigoid; Infectious Keratoconjunctivitis
• Interventions: Diagnostic Test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry

• Registration Number: NCT04198740
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Study Start: 2020-02-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19
• Primary Completion: 2034-10
• Study Completion: 2035-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry	Healthy, normal ocular surface
Dry eye syndrome	Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry	Patients suffering from either: * Lacrimal insufficiency * Anterior blepharitis * Posterior blepharitis * Sjögren syndrome
Allergic conjunctivitis	Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry	Patients suffering from allergic conjunctivitis
Mucous membrane pemphigoid	Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry	Patients suffering from mucous membrane pemphigoid
Infectious keratoconjunctivitis	Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry	Patients suffering from keratitis and/or conjunctivitis of various etiology: * Viral * Bacterial * Fungal * Acanthamoeba

Primary Outcome Measures

Name	Time	Method
To obtain the metabolomic and proteomic fingerprint of the studied ocular surface pathologies	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

Name	Time	Method
To objectify changes in metabolomic and proteomic profile associated with topical treatments taken by participants in this study	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.

Trial Locations

Locations (2)

Université du Québec à Montréal (UQAM) - Department of Chemistry; 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier de l'Université de Montréal (CHUM); 🇨🇦 Montreal, Quebec, Canada