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

NCT04198740 | Recruiting

• 1 other identifier: CE19.212
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Lacrimal fingerprint; Metabolomics; Proteomics; Ocular surface

Outcome Measures

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.

  5 years

Secondary Outcomes (1)

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

  5 years

Study Arms (5)

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

Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry DIAGNOSTIC_TEST

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; Control group; Dry eye syndrome; Infectious keratoconjunctivitis; Mucous membrane pemphigoid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with healthy corneas or suffering from one of these pathologies:
• Dry eye syndrome; Infectious keratitis and/or conjunctivitis; Mucous membrane pemphigoid; Allergic conjunctivitis.

You may not qualify if:

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Université du Québec a Montréal: collaborator

Study Sites (2)

Université du Québec à Montréal (UQAM) - Department of Chemistry

Montreal, Quebec, H2X 2J6, Canada

ACTIVE NOT RECRUITING

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Related Publications (10)

• 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.

  PMID: 15911533 BACKGROUND

• 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.

  PMID: 24921002 BACKGROUND

• 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.

  PMID: 22634083 BACKGROUND

• 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.

  PMID: 23769845 BACKGROUND

• 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.

  PMID: 16901338 BACKGROUND

• 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.

  PMID: 27413414 BACKGROUND

• 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.

  PMID: 28736338 BACKGROUND

• 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.

  PMID: 23272196 BACKGROUND

• 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.

  PMID: 20508732 BACKGROUND

• 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.

  PMID: 18334958 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis, Infectious; Pemphigoid, Benign Mucous Membrane; Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Animal Diseases; Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Marie-Claude Robert, MD, M.Sc

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Claude Robert, MD, M.Sc

CONTACT

514-890-8278; marie-claude.robert.2@umontreal.ca

Marie-Catherine Tessier

CONTACT

514-890-8000; marie-catherine.tessier.chum@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 13, 2019
• Study Start: February 1, 2020
• Primary Completion (Estimated): October 1, 2034
• Study Completion (Estimated): January 1, 2035
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)