Clinical trial NCT04198740: Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface
Official title: Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dry Eye Syndrome
Infectious Keratoconjunctivitis
Mucous Membrane Pemphigoid
Allergic Conjunctivitis
Keywords: Lacrimal fingerprint
Metabolomics
Proteomics
Ocular surface
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Université du Québec a Montréal
First posted: 2019-12-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting at the cornea service of the ophthalmology department of the 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.

Eligibility 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.

Primary outcomes:
measure: To obtain the metabolomic and proteomic fingerprint of the studied ocular surface pathologies
timeFrame: 5 years
Secondary outcomes:
measure: To objectify changes in metabolomic and proteomic profile associated with topical treatments taken by participants in this study
timeFrame: 5 years
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Université du Québec à Montréal (UQAM) - Department of Chemistry
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Marie-Claude Robert, MD, M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
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