ClinicalTrials.gg
RecruitingNCT04198740EML-MSOUpdated Apr 27, 2026

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

An observational study in Dry Eye Syndrome, Infectious Keratoconjunctivitis and Mucous Membrane Pemphigoid, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 2 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-27.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Observational

From the registry’s dates

  • Started Feb 2020; still recruiting 6 years 9 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dry Eye Syndrome
  • Infectious Keratoconjunctivitis
  • Mucous Membrane Pemphigoid
  • Allergic Conjunctivitis

Keywords

  • Lacrimal fingerprint
  • Metabolomics
  • Proteomics
  • Ocular surface
03

In context

Dry Eye Syndromes

1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.

This study's planned enrollment of 300 is above the median of 89 across 190 observational studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients younger than 18 years old;
  • Patients incapable of giving .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Control group

    Healthy, normal ocular surface

    Diagnostic Test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry

  • 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

  • Allergic conjunctivitis

    Patients suffering from allergic conjunctivitis

    Diagnostic Test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry

  • Mucous membrane pemphigoid

    Patients suffering from mucous membrane pemphigoid

    Diagnostic Test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry

  • 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

Interventions

  • Diagnostic testTear 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.

06

What researchers measure

Primary outcomes

  1. To obtain the metabolomic and proteomic fingerprint of the studied ocular surface pathologies

    Raw data will be analysed with MarkerView software by Sciex to identify specific over- or under-expressed markers in these ocular pathologies.

    Time frame: 5 years

Secondary outcomes

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

    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.

    Time frame: 5 years

07

Study locations

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

    Not enrolling at this site.

  • Centre Hospitalier de l'Université de Montréal (CHUM)
    Montreal, Quebec H2X 3E4, Canada
    Recruiting
08

References and documents

Publications

  • Karring H, Thogersen IB, Klintworth GK, Moller-Pedersen T, Enghild JJ. A dataset of human cornea proteins identified by Peptide mass fingerprinting and tandem mass spectrometry. Mol Cell Proteomics. 2005 Sep;4(9):1406-8. doi: 10.1074/mcp.D500003-MCP200. Epub 2005 May 23. PubMed 15911533 ↗
  • Elsobky S, Crane AM, Margolis M, Carreon TA, Bhattacharya SK. Review of application of mass spectrometry for analyses of anterior eye proteome. World J Biol Chem. 2014 May 26;5(2):106-14. doi: 10.4331/wjbc.v5.i2.106. PubMed 24921002 ↗
  • Zhou L, Zhao SZ, Koh SK, Chen L, Vaz C, Tanavde V, Li XR, Beuerman RW. In-depth analysis of the human tear proteome. J Proteomics. 2012 Jul 16;75(13):3877-85. doi: 10.1016/j.jprot.2012.04.053. Epub 2012 May 23. PubMed 22634083 ↗
  • Karnati R, Laurie DE, Laurie GW. Lacritin and the tear proteome as natural replacement therapy for dry eye. Exp Eye Res. 2013 Dec;117:39-52. doi: 10.1016/j.exer.2013.05.020. Epub 2013 Jun 12. PubMed 23769845 ↗
  • de Souza GA, Godoy LM, Mann M. Identification of 491 proteins in the tear fluid proteome reveals a large number of proteases and protease inhibitors. Genome Biol. 2006;7(8):R72. doi: 10.1186/gb-2006-7-8-R72. Epub 2006 Aug 10. PubMed 16901338 ↗
  • Hagan S, Martin E, Enriquez-de-Salamanca A. Tear fluid biomarkers in ocular and systemic disease: potential use for predictive, preventive and personalised medicine. EPMA J. 2016 Jul 13;7(1):15. doi: 10.1186/s13167-016-0065-3. eCollection 2016. PubMed 27413414 ↗
  • Willcox MDP, Argueso P, Georgiev GA, Holopainen JM, Laurie GW, Millar TJ, Papas EB, Rolland JP, Schmidt TA, Stahl U, Suarez T, Subbaraman LN, Ucakhan OO, Jones L. TFOS DEWS II Tear Film Report. Ocul Surf. 2017 Jul;15(3):366-403. doi: 10.1016/j.jtos.2017.03.006. Epub 2017 Jul 20. PubMed 28736338 ↗
  • Aluru SV, Agarwal S, Srinivasan B, Iyer GK, Rajappa SM, Tatu U, Padmanabhan P, Subramanian N, Narayanasamy A. Lacrimal proline rich 4 (LPRR4) protein in the tear fluid is a potential biomarker of dry eye syndrome. PLoS One. 2012;7(12):e51979. doi: 10.1371/journal.pone.0051979. Epub 2012 Dec 18. PubMed 23272196 ↗
  • Enriquez-de-Salamanca A, Castellanos E, Stern ME, Fernandez I, Carreno E, Garcia-Vazquez C, Herreras JM, Calonge M. Tear cytokine and chemokine analysis and clinical correlations in evaporative-type dry eye disease. Mol Vis. 2010 May 19;16:862-73. PubMed 20508732 ↗
  • Green-Church KB, Nichols KK, Kleinholz NM, Zhang L, Nichols JJ. Investigation of the human tear film proteome using multiple proteomic approaches. Mol Vis. 2008 Mar 7;14:456-70. PubMed 18334958 ↗

Individual participant data

Plan to share: No — The investigators do not plan to share individual participant data.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04198740
Collaborators
Université du Québec a Montréal
Responsible party
Sponsor
First posted
Dec 13, 2019
Start date
Feb 1, 2020
Primary completion
Oct 2034 (estimated)
Completion
Jan 2035 (estimated)
Last update
Apr 27, 2026

Study contacts

Marie-Claude Robert, MD, M.Sc
Contact
marie-claude.robert.2@umontreal.ca
514-890-8278
Marie-Catherine Tessier
Contact
marie-catherine.tessier.chum@ssss.gouv.qc.ca
514-890-8000 ext. 11550
Marie-Claude Robert, MD, M.Sc
principal investigator · Centre hospitalier de l'Université de Montréal (CHUM)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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