Amyotrophic Lateral SclerosisLARMOMIQUENCT04953286
Ocular Surface Metabolo-lipidomics in Lateral Amyotrophic Sclerosis
A study testing Measure of visual acuity, Interferometry and Samples of basal tears in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Tours at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Measure of visual acuity, Interferometry and Samples of basal tears
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 3 sitesFrance
- Study dates
- 17 Sep 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- No diagnosed neurological pathology
Show all 9Show fewer
- ≥18 years of age
- Patient affiliated with a social security plan
- Informed consent signed by the participant
Who cannot join
- 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
Show all 18Show fewer
- 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:
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Ophthalmology Department, University Hospital of Tours, France
Tours, 37000
Neurology Department, University Hospital of Tours, France
Tours, 37044
Centre d'Investigation Clinique_CIC 1415
Tours
About this study
Official title: 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
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Measure of visual acuity, Interferometry, Samples of basal tears, Central corneal sensitivity, Slit lamp examination and undilated fundus
- Keywords
- Amyotrophic Lateral Sclerosis, Biomarkers, Ocular Surface, Tear
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of visual acuityOther
ETDRS and Parinaud scale
InterferometryOther
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
Samples of basal tearsOther
Collection of basal tears without instillation of anesthetic with a Schirmer strip for 5 minutes and by microcapillary
Central corneal sensitivityOther
Central corneal sensitivity using a Cochet-Bonnet esthesiometer (Luneau©)
Slit lamp examination and undilated fundusOther
Slit lamp examination and undilated fundus
Conjunctival impressionOther
Conjunctival impression with anesthetic instillation
Evaluation of the corneal innervationOther
Contact corneal confocal microscopy
| Study group | Role | What they receive |
|---|---|---|
| Case group | Other | 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 Receives: Other: Measure of visual acuity; Other: Interferometry; Other: Samples of basal tears; Other: Central corneal sensitivity; Other: Slit lamp examination and undilated fundus; Other: Conjunctival impression; Other: Evaluation of the corneal innervation |
| Control group | Other | 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 Receives: Other: Measure of visual acuity; Other: Interferometry; Other: Samples of basal tears; Other: Central corneal sensitivity; Other: Slit lamp examination and undilated fundus; Other: Conjunctival impression; Other: Evaluation of the corneal innervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolome profile in tears for the diagnosis and prognosis of ALS.
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
Measured: Baseline
Metabolome profile in intra-cellular contents for the diagnosis and prognosis of ALS.
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.
Measured: Baseline
Lipidome profile in tears for the diagnosis and prognosis of ALS.
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
Measured: Baseline
Lipidome profile in intra-cellular contents for the diagnosis and prognosis of ALS.
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.
Measured: Baseline
Secondary outcomes (2)
Evolution of the ocular surface metabolites during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry
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).
Measured: Baseline
Evolution of the ocular surface lipids during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start17 Sep 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953286
- Sponsor's protocol ID
- DR210051
- Acronym
- LARMOMIQUE
- Status last verified
- Nov 2023
- First submitted
- 17 May 2021
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khanna RK, Catanese S, Mortemousque G, Dupuy C, Lefevre A, Emond P, Beltran S, Gissot V, Pisella PJ, Blasco H, Corcia P. Metabolomics of basal tears in amyotrophic lateral sclerosis: A cross-sectional study. Ocul Surf. 2024 Oct;34:363-369. doi: 10.1016/j.jtos.2024.09.005. Epub 2024 Sep 28.
PubMed 39349171
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tear Fluid and Ocular Surface Metabolomics and Lipidomics in Lateral Amyotrophic Sclerosis: a Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT04953286
- Acronym / sponsor ID
- LARMOMIQUE / DR210051
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic Lateral Sclerosis, Biomarkers, Ocular Surface, Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 7 Jul 2021 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | Other | Other: Measure of visual acuity, Other: Interferometry, Other: Samples of basal tears, Other: Central corneal sensitivity, Other: Slit lamp examination and undilated fundus, Other: Conjunctival impression, Other: Evaluation of the corneal innervationThe 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 |
| Control group | Other | Other: Measure of visual acuity, Other: Interferometry, Other: Samples of basal tears, Other: Central corneal sensitivity, Other: Slit lamp examination and undilated fundus, Other: Conjunctival impression, Other: Evaluation of the corneal innervationThe 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
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 |
|---|---|---|
| Measure of visual acuityETDRS and Parinaud scale | Other | Case group, Control group |
| InterferometryNon-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 | Case group, Control group |
| Samples of basal tearsCollection of basal tears without instillation of anesthetic with a Schirmer strip for 5 minutes and by microcapillary | Other | Case group, Control group |
| Central corneal sensitivityCentral corneal sensitivity using a Cochet-Bonnet esthesiometer (Luneau©) | Other | Case group, Control group |
| Slit lamp examination and undilated fundusSlit lamp examination and undilated fundus | Other | Case group, Control group |
| Conjunctival impressionConjunctival impression with anesthetic instillation | Other | Case group, Control group |
| Evaluation of the corneal innervationContact corneal confocal microscopy | Other | Case group, Control group |
Primary outcome
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
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.
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
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.
2 secondary outcomes
Evolution of the ocular surface metabolites during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry
Time frame: Baseline
Evolution of the ocular surface lipids during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 39349171Khanna RK, Catanese S, Mortemousque G, Dupuy C, Lefevre A, Emond P, Beltran S, Gissot V, Pisella PJ, Blasco H, Corcia P. Metabolomics of basal tears in amyotrophic lateral sclerosis: A cross-sectional study. Ocul Surf. 2024 Oct;34:363-369. doi: 10.1016/j.jtos.2024.09.005. Epub 2024 Sep 28.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measure of visual acuity, Interferometry and Samples of basal tears in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Tours at 3 sites in France.
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 9 inclusion and 18 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: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolome profile in tears for the diagnosis and prognosis of ALS. (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT04953286, which also lists 1 linked publication.
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 22 Dec 2025.