Ocular Surface Metabolo-lipidomics in Lateral Amyotrophic Sclerosis (LARMOMIQUE)

December 15, 2025 updated by: University Hospital, Tours

Tear Fluid and Ocular Surface Metabolomics and Lipidomics in Lateral Amyotrophic Sclerosis: a Prospective Comparative Study

Amyotrophic Lateral Sclerosis (ALS) is the most common neurodegenerative disease affecting the motor neuron. Currently, there is no diagnostic test and no examination that can predict the evolution of this pathology. The search for diagnostic and prognostic biomarkers is therefore essential for a better understanding of the pathophysiology of ALS, which remains poorly understood, and also for better clinical management. The ocular surface, made up of liquid elements, tears, and cells, is an accessible anatomical-physiological entity that has demonstrated its usefulness in the identification of biomarkers in neurodegenerative diseases such as Parkinson's or Alzheimer's. To date, no study has explored the ocular surface as a biomarker in ALS

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37000
        • Ophthalmology Department, University Hospital of Tours, France
      • Tours, France, 37044
        • Neurology Department, University Hospital of Tours, France
      • Tours, France
        • Centre d'Investigation Clinique_CIC 1415

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Case group selection criteria :

Inclusion Criteria:

  • Patient with clinically defined or probable primary ALS according to Airlie House criteria(1)
  • Familial or sporadic form
  • ≥18 years of age
  • Patient affiliated with a social security plan
  • Informed consent signed by the patient

Exclusion Criteria:

  • Motor neuron disease mimicking ALS
  • Pregnant or breastfeeding woman
  • Treatment that may have a neuroprotective effect
  • Any eye drops or treatments that may interfere with tear production
  • Lens wearer
  • Eye surgery ≤3 months
  • Any ocular pathology other than ametropia, oculomotor disorder, amblyopia
  • Any general pathology other than ALS with ocular repercussions
  • Protective measure of guardianship or curators

Control group selection criteria:

Inclusion Criteria:

  • No diagnosed neurological pathology
  • ≥18 years of age
  • Patient affiliated with a social security plan
  • Informed consent signed by the participant

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Treatment likely to have a neuroprotective effect
  • Any eye drops or treatments that may interfere with tear production
  • Lens wearer
  • Eye surgery ≤3 months
  • Any ocular pathology except ametropia, oculomotor disorder, amblyopia
  • Any general pathology with ocular repercussions
  • Protective measure of guardianship or curator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Case group
The procedure, specific to the study, consists in taking samples of tears and cells at inclusion, 3 months after inclusion and 6 months after inclusion on patients with Amyotrophic Lateral Sclerosis
Other: Measure of visual acuity
ETDRS and Parinaud scale
Other: Interferometry
Non-contact exam measuring N.I.B.U.T (Non-invasive break-up time), quantitative and qualitative evaluation of the meibomian glands and quantitative evaluation of the tear meniscus
Other: Samples of basal tears
Collection of basal tears without instillation of anesthetic with a Schirmer strip for 5 minutes and by microcapillary
Other: Central corneal sensitivity
Central corneal sensitivity using a Cochet-Bonnet esthesiometer (Luneau©)
Other: Slit lamp examination and undilated fundus
Slit lamp examination and undilated fundus
Other: Conjunctival impression
Conjunctival impression with anesthetic instillation
Other: Evaluation of the corneal innervation
Contact corneal confocal microscopy
Other: Control group
The procedure, specific to the study, consists in taking samples of tears and cells at inclusion, 3 months after inclusion and 6 months after inclusion on patients without neurological disease
Other: Measure of visual acuity
ETDRS and Parinaud scale
Other: Interferometry
Non-contact exam measuring N.I.B.U.T (Non-invasive break-up time), quantitative and qualitative evaluation of the meibomian glands and quantitative evaluation of the tear meniscus
Other: Samples of basal tears
Collection of basal tears without instillation of anesthetic with a Schirmer strip for 5 minutes and by microcapillary
Other: Central corneal sensitivity
Central corneal sensitivity using a Cochet-Bonnet esthesiometer (Luneau©)
Other: Slit lamp examination and undilated fundus
Slit lamp examination and undilated fundus
Other: Conjunctival impression
Conjunctival impression with anesthetic instillation
Other: Evaluation of the corneal innervation
Contact corneal confocal microscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolome profile in tears for the diagnosis and prognosis of ALS.
Time Frame: Baseline
Once the composition in metabolites (i.e. tear metabolome) is determined, statistical univariate and multivariate analyses will aim to determine if the tear metabolome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker
Baseline
Metabolome profile in intra-cellular contents for the diagnosis and prognosis of ALS.
Time Frame: Baseline
Once the composition in metabolites in conjunctival cells is determined, statistical univariate and multivariate analyses will aim to determine if the tear metabome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker.
Baseline
Lipidome profile in tears for the diagnosis and prognosis of ALS.
Time Frame: Baseline
Once the composition in lipids (i.e. tear lipidome) is determined, statistical univariate and multivariate analyses will aim to determine if the tear lipidome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker
Baseline
Lipidome profile in intra-cellular contents for the diagnosis and prognosis of ALS.
Time Frame: Baseline
Once the composition in lipids in conjunctival cells is determined, statistical univariate and multivariate analyses will aim to determine if the tear lipidome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of the ocular surface metabolites during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry
Time Frame: Baseline
By carrying out a longitudinal analysis in ALS cases, the modification in tear and cells metabo-lipidome will be assessed at three time-points (at diagnosis, at month 3 and 6) and will correlated with bioclinical criteria of ALS progression (i.e. % of weight loss, % of slope of progression of the ALS-FRS-r score and % of decrease in forced vital capacity). This analysis will aim to search for analytes that can predict ALS progression (i.e. prognosis biomarker).
Baseline
Evolution of the ocular surface lipids during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry
Time Frame: Baseline
By carrying out a longitudinal analysis in ALS cases, the modification in tear and cells metabo-lipidome will be assessed at three time-points (at diagnosis, at month 3 and 6) and will correlated with bioclinical criteria of ALS progression (i.e. % of weight loss, % of slope of progression of the ALS-FRS-r score and % of decrease in forced vital capacity). This analysis will aim to search for analytes that can predict ALS progression (i.e. prognosis biomarker).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2021

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

July 6, 2021

First Posted (Actual)

July 7, 2021

Study Record Updates

Last Update Posted (Estimated)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR210051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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