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

Dry Eye Syndrome Clinical Trial

— EML-MSO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04198740
• Other study ID #: CE19.212
• Status: Recruiting
• Start date: February 1, 2020
• Est. completion date: January 2035

Study information

• Verified date: April 2024
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Marie-Claude Robert, MD, M.Sc
• Phone: 514-890-8278
• Email: marie-claude.robert.2[@]umontreal.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2035
• Est. primary completion date: October 2034
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic
• Dry Eye Syndrome
• Dry Eye Syndromes
• Infectious Keratoconjunctivitis
• Keratoconjunctivitis
• Mucous Membrane Pemphigoid
• Pemphigoid, Bullous

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec
Canada	Université du Québec à Montréal (UQAM) - Department of Chemistry	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Université du Québec a Montréal

Country where clinical trial is conducted

Canada, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	5 years