Dry Eye SyndromeEML-MSONCT04198740
Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface
An observational study of Dry Eye Syndrome and Infectious Keratoconjunctivitis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome, Infectious Keratoconjunctivitis, Mucous Membrane Pemphigoid
- What is being tested?
- Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry
- How many people
- 300 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Feb 2020to Jan 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients consulting at the cornea service of the ophthalmology department of the CHUM.
Who may be able to join
- Patients with healthy corneas or suffering from one of these pathologies:
- Dry eye syndrome; Infectious keratitis and/or conjunctivitis; Mucous membrane pemphigoid; Allergic conjunctivitis.
Who cannot join
- Patients younger than 18 years old;
- Patients incapable of giving informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 1 recruiting
- Active, not recruiting
Université du Québec à Montréal (UQAM) - Department of Chemistry
Montreal, Quebec, H2X 2J6
- Recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
Marie-Claude Robert, MD, M.Sc, 514-890-8278, marie-claude.robert.2@umontreal.ca
Marie-Catherine Tessier, 514-890-8000 ext. 11550, marie-catherine.tessier.chum@ssss.gouv.qc.ca
About this study
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.
- Conditions
- Dry Eye Syndrome, Infectious Keratoconjunctivitis, Mucous Membrane Pemphigoid, Allergic Conjunctivitis
- Being tested
- Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry
- Keywords
- Lacrimal fingerprint, Metabolomics, Proteomics, Ocular surface
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis, Infectious, Pemphigoid, Benign Mucous Membrane, Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometryDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Healthy, normal ocular surface Receives: 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 Receives: Diagnostic Test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry | |
| Allergic conjunctivitis | Patients suffering from allergic conjunctivitis Receives: Diagnostic Test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry | |
| Mucous membrane pemphigoid | Patients suffering from mucous membrane pemphigoid Receives: 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 Receives: Diagnostic Test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Feb 2020
- Primary completionOct 2034 (estimated)
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Université du Québec a Montréal
- Responsible party
- Sponsor
- Investigators
- Marie-Claude Robert, MD, M.Sc, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198740
- Sponsor's protocol ID
- CE19.212
- Acronym
- EML-MSO
- Status last verified
- Apr 2026
- First submitted
- 9 Dec 2019
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share individual participant data.
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 15911533Elsobky 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 24921002Zhou 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 22634083Karnati 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 23769845de 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 16901338Hagan 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 27413414Willcox 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 28736338Aluru 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 23272196Enriquez-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 20508732Green-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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface
- ClinicalTrials.gov ID
- NCT04198740
- Acronym / sponsor ID
- EML-MSO / CE19.212
- Conditions
- Dry Eye Syndrome, Infectious Keratoconjunctivitis, Mucous Membrane Pemphigoid, Allergic Conjunctivitis
- Keywords
- Lacrimal fingerprint, Metabolomics, Proteomics, Ocular surface
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Université du Québec a Montréal
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- Oct 2034 (estimated)
- Study completion
- Jan 2035 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometryHealthy, normal ocular surface |
| Dry eye syndrome | – | Diagnostic Test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometryPatients suffering from either: * Lacrimal insufficiency * Anterior blepharitis * Posterior blepharitis * Sjögren syndrome |
| Allergic conjunctivitis | – | Diagnostic Test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometryPatients suffering from allergic conjunctivitis |
| Mucous membrane pemphigoid | – | Diagnostic Test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometryPatients suffering from mucous membrane pemphigoid |
| Infectious keratoconjunctivitis | – | Diagnostic Test: Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometryPatients suffering from keratitis and/or conjunctivitis of various etiology: * Viral * Bacterial * Fungal * Acanthamoeba |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting at the cornea service of the ophthalmology department of the CHUM.
Key inclusion criteria (2 listed)
- Patients with healthy corneas or suffering from one of these pathologies:
- Dry eye syndrome; Infectious keratitis and/or conjunctivitis; Mucous membrane pemphigoid; Allergic conjunctivitis.
Key exclusion criteria (2 listed)
- Patients younger than 18 years old;
- Patients incapable of giving informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometryDuring 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. | Diagnostic test | Allergic conjunctivitis, Control group, Dry eye syndrome, Infectious keratoconjunctivitis, Mucous membrane pemphigoid |
Primary outcome
To obtain the metabolomic and proteomic fingerprint of the studied ocular surface pathologies
Time frame: 5 years
Raw data will be analysed with MarkerView software by Sciex to identify specific over- or under-expressed markers in these ocular pathologies.
1 secondary outcome
To objectify changes in metabolomic and proteomic profile associated with topical treatments taken by participants in this study
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 15911533Karring 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.
- Background: PubMed 24921002Elsobky 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.
- Background: PubMed 22634083Zhou 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.
- Background: PubMed 23769845Karnati 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.
- Background: PubMed 16901338de 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.
- Background: PubMed 27413414Hagan 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.
- Background: PubMed 28736338Willcox 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.
- Background: PubMed 23272196Aluru 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.
- Background: PubMed 20508732Enriquez-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.
- Background: PubMed 18334958Green-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.
- Individual participant dataSharing planned: No. The investigators do not plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Claude Robert, MD, M.Sc principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Syndrome and Infectious Keratoconjunctivitis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Claude Robert, MD, M.Sc (514-890-8278, marie-claude.robert.2@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To obtain the metabolomic and proteomic fingerprint of the studied ocular surface pathologies (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04198740, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.