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Recruiting NCT04198740

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

Observational Dry Eye Syndrome Infectious Keratoconjunctivitis Mucous Membrane Pemphigoid Allergic Conjunctivitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry.
Who it may be relevant to
Registry conditions: Dry Eye Syndrome, Infectious Keratoconjunctivitis, Mucous Membrane Pemphigoid, Allergic Conjunctivitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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

  • To obtain the metabolomic and proteomic fingerprint of the studied ocular surface pathologies [Time frame: 5 years]
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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Canada · 2 centers
  • Université du Québec à Montréal (UQAM) - Department of Chemistry — Montreal
  • Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 23272196

Identifiers

NCT: NCT04198740 · CE19.212

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗