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TerminatedNCT02016222LARMESUpdated Jun 11, 2026

Tear Analysis in the Diagnosis of Multiple Sclerosis

An interventional study of tears sampling in Primary Progressive Multiple Sclerosis, sponsored by Lille Catholic University. Terminated at 13 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by Lille Catholic University · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Difficulties encountered in recruiting patients
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

In the primary progressive multiple sclerosis, the detection of oligoclonal bands in cerebrospinal fluid is critical for the diagnosis. However, lumbar puncture for cerebrospinal fluid collection is considered relatively invasive. Our hypothesis is that oligoclonal bands detection in tears is possible and useful for the diagnosis of multiple sclerosis.

Read the detailed description

The objective of the present study is to assess concordance between oligoclonal bands detection in tears and in cerebrospinal fluid. We will include patients with primary progressive multiple sclerosis and we will compare results of oligoclonal bands detection by isoelectric focusing in cerebrospinal fluid and tears. Tears will be collected using a Schirmer strip. This would circumvent the practice of invasive lumbar punctures currently used in multiple sclerosis diagnosis.

02

Conditions studied

  • Primary Progressive Multiple Sclerosis

Keywords

  • primary progressive multiple sclerosis
  • diagnosis
  • tears
  • isoelectric focusing
  • oligoclonal bands
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 years old or more
  • Progressive neurological deficit after 12 months
  • At least 9 T2 brain lesions of minimum 3 mm evidenced by MRI and/or four or more T2 lesions of minimum 3 mm with positive Visual Evoked Potential and/or positive spinal cord MRI (at least two focal T2 lesions)

Exclusion criteria

Exclusion Criteria:

  • Asiatic persons
  • recurrent forms of the disease
  • Persons wearing contact lenses
  • Ocular Infection
  • Corticoid treatment at least 30 days before sampling
  • immunosuppressive or immunomodulatory treatment 3 months before sampling
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Tears sampling

    Procedure: tears sampling

Interventions

  • Proceduretears sampling
05

What researchers measure

Primary outcomes

  1. Concordance between the quantification of oligoclonal IgG bands by isoelectric focusing in tears and in the cerebrospinal fluid in patients with primary progressive multiple sclerosis

    Time frame: at baseline and two years after (+/- 2 months)

Secondary outcomes

  1. Isoelectrophoretic profile of tears

    Determination of the stability and prognostic value of isoelectrophoretic profile of tears at inclusion, after 2 years.

    Time frame: Baseline and two years after inclusion

  2. Isoelectrophoretic profiles of tears by digital recording and analysis of images

    Time frame: Baseline and two years after

06

Study locations

13 sites
  • Centre hospitalier universitaire (CHU), Nice
    Nice, Alpes Maritimes 06003, France
  • Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
    Lille, Nord 59000, France
  • Centre hospitaliere universitaire
    Bordeaux, 33404, France
  • Centre hospitalier universitaire
    Caen, 14033, France
  • Centre hospitalier régional universitaire
    Clermont-Ferrand, 63003, France
  • Centre hospitalier universitaire
    Dijon, 21079, France
  • Centre hospitalier régional universitaire
    Lille, 59037, France
  • Hospices civils de Lyon
    Lyon, 69229, France
  • Assistance Publique - Hôpitaux de Marseille
    Marseille, 13354, France
  • Centre hospitalier universitaire
    Nancy, 54035, France
  • Centre hospitalier universitaire
    Nîmes, 30029, France
  • Centre hospitalier intercommunal
    Poissy, 78303, France
  • Centre hospitalier régional universtaire
    Strasbourg, 67091, France
07

Registry details

Key details

Study ID
NCT02016222
Lead sponsor
Lille Catholic University
Collaborators
Bayer
Responsible party
Sponsor
First posted
Dec 19, 2013
Start date
Apr 2011
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Jun 11, 2026

Study contacts

Patrick Hautecoeur, MD
principal investigator · Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
Elisabeth Baumelou, MD
study chair · Groupement des Hôpitaux de l'Institut Catholique de Lille
Patrick Vermersch, MD, PhD
principal investigator · Centre Hospitalier Régional, Universitaire de Lille
Christine Lebrun-Frenay, MD, PhD
principal investigator · Centre Hospitalier Universitaire de Nice
Jérome De Sèze, MD, PhD
principal investigator · Centre Hospitalier Régional Universitaire de Strasbourg
Thibaut Moreau, MD
principal investigator · Centre Hospitalier Universitaire Dijon
Pierre Clavelou, MD
principal investigator · Centre Hospitalier Régional Universitaire de Clermont-Ferrand
Olivier Heinzlef, MD
principal investigator · Centre hospitalier intercommunal de Poissy
Christian Confavreux, MD
principal investigator · Hospices Civils de Lyon
Marc Debouverie, MD, PhD
principal investigator · Central Hospital, Nancy, France
Jean Pelletier, MD, PhD
principal investigator · L'assistance Publique des Hôpitaux de Marseille
Bruno Brochet, MD, PhD
principal investigator · University Hospital, Bordeaux
Gilles Defer, MD
principal investigator · Centre Hospitalier Universitaire de Caen
Eric Thouvenot, MD
principal investigator · Centre Hospitalier Universitaire de Nīmes

Oversight

Data monitoring committee
No
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