Dry EyeLACRYMOSANCT04093037

Analysis of the Diagnostic Performance of LacryDiag, a New Analyzer of the Ocular Surface in the Dry Eye

A study testing Time #1: Non Invasive Break-Up Time (NIBUT), Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score and Time #3: Standard Break-Up Time (SBUT) in people with Dry Eye, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye
What is being tested?: Time #1: Non Invasive Break-Up Time (NIBUT), Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score and Time #3: Standard Break-Up Time (SBUT)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteFrance
Study dates: 14 Nov 2019to 27 Aug 2020
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Affiliates or beneficiaries of social security scheme
With Dry eye of any cause, diagnosed with conventional means
Signed informed consent

Who cannot join

Major blepharospasm
Serious illness preventing participation according to investigator
Allergy to fluorescein
Pregnant or / and breastfeeding women
Under guardianship, curatorship or safeguard of justice
Unable to express their consent
Person in emergency situation

Trial locations and contacts

1 site in 1 country.

France1 site

Chu Saint-Etienne
Saint-Etienne

Other trials in France

About this study

Official title: Analysis of the Diagnostic Performance of LacryDiag, a New "All-in-one" Non-contact Analyzer of the Ocular Surface in the Dry Eye. Study LACRYMOSA

LacryDiag is a new Conformity European (CE) marked diagnostic imaging device devoted to the analysis of the ocular surface. It is an "all in one" device that provides 4 data: non-invasive break-up time (Non-Invasive Break-Up-Time (NIBUT) without fluorescein eye drop); height of the Tear Meniscus (TM); an infrared image of the meibomian glands; a picture of the lacrimal film by interferometry. it's performance will be compare between in diagnosing dry eye syndrome with the standard clinical evaluation, in 80 patients suffering from dry eye diseases and followed at the consultation of the Ophthalmology department of the University Hospital of Saint-Etienne.

Read the detailed description

The primary purpose of this study is to compare the value of Break-Up-Time (BUT) between Non-Invasive Break-Up-Time (NIBUT) measured by LacryDiag and Standard Break-Up-Time (SBUT) measured by usual practice.

Conditions: Dry Eye
Being tested: Time #1: Non Invasive Break-Up Time (NIBUT), Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score, Time #3: Standard Break-Up Time (SBUT), Time #4: Schirmer test, Satisfaction questionnaire to the patient
Keywords: Dry eye, LacryDiag, Fluorescein, Break-Up Time (BUT), Schirmer test, Lacrimal film, Oxford score, Meibomian Gland, Tear Meniscus (TM), Non Invasive Break-Up Time (NIBUT)
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Time #1: Non Invasive Break-Up Time (NIBUT)Diagnostic test
Also called LacryDiag, Complete diagnosis of dry eyes
A LacryDiag examination without dye will be realized. All measurements are made without contact. It's calculates the Non Invasive Break-Up Time (NIBUT), Tear Meniscus (TM) height (in millimeters) and number of Meibomian Gland.
These are different pictures taken with LacryDiag and analyzed.
Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford scoreDiagnostic test
The MicroInstillation of fluorescein Break-Up Time (MIBUT) will be calculated by manual MIBUT and LacryDiag MIBUT.
The Oxford score will be calculated. It's used to clinically determine the severity of dry eyes with minimum score at 0 (none) and maximum score at 5 (very severity).
Time #3: Standard Break-Up Time (SBUT)Diagnostic test
The Standard Break-Up Time (SBUT) with fluorescein macroinstillation will be calculated by manual SBUT and LacryDiag SBUT.
Time #4: Schirmer testDiagnostic test
The Schirmer test will be performed. It consists of applying the end of a small strip of blotting paper behind the lower eyelid and examining the strip after 5 minutes.
Satisfaction questionnaire to the patientDiagnostic test
A satisfaction questionnaire to the patient will be completed at the end of the participation at the study.

Study groups in NCT04093037
Study group	Role	What they receive
Patient with dry eye disease	Experimental	Patient with dry eye disease will be included. They will have: * Time #1: LacryDiag examination without dye * Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score * Time #3: Standard Break-Up Time (SBUT) * Time #4: Schirmer test * Satisfaction questionnaire to the patient Receives: Diagnostic Test: Time #1: Non Invasive Break-Up Time (NIBUT); Diagnostic Test: Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score; Diagnostic Test: Time #3: Standard Break-Up Time (SBUT); Diagnostic Test: Time #4: Schirmer test; Diagnostic Test: Satisfaction questionnaire to the patient

What is being measured

The primary outcome is the main question the study is designed to answer.

Break-Up-Time (BUT)
Comparison of Break-Up-Time (BUT) measured by 2 methods : LacryDiag Non Invasive Break-Up Time (NIBUT) and manual Standard Break-Up Time (SBUT).
Measured in seconds by time#1: Non Invasive Break-Up Time (NIBUT) and time#3: Standard Break-Up Time (SBUT).
Measured: Day: 1

Secondary outcomes (5)

Standard Break-Up Time (SBUT)
Comparison of Standard Break-Up Time (SBUT) between LacryDiag SBUT results and manual SBUT results. Measured in seconds.
Measured by time#3: Standard Break-Up Time (SBUT).
Measured: Day: 1
MicroInstillation Break-Up Time (MIBUT)
Comparison of MicroInstillation Break-Up Time (MIBUT) between LacryDiag MIBUT results and manual MIBUT results.
Measured in seconds by time#1: Non Invasive Break-Up Time (NIBUT) and time#2: MicroInstillation Break-Up Time (MIBUT).
Measured: Day: 1
Tear Meniscus (TM) height and Schirmer test
Correlation between Tear Meniscus (TM) height (in millimeters) and Schirmer test (in millimeters).
Measured by time#1: Non Invasive Break-Up Time (NIBUT) and time#4: Schirmer test.
Measured: Day: 1
Percentage loss of Meibomian Gland.
Measured by time#1: Non Invasive Break-Up Time (NIBUT).
Measured: Day: 1
Thickness (in nanometer) and regularity of lacrimal film (type)
Correlation between measure thickness (in nanometer) and regularity of lacrimal film (type).
Measured by time#1: Non Invasive Break-Up Time (NIBUT).
Measured: Day: 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Nov 201927 Aug 2020

First posted17 Sep 2019
Study start14 Nov 2019
Primary completion27 Aug 2020
Study completion27 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Dry EyeStudies of the same condition, open and under way.
More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Model description: 80 patients divided into 4 subgroups according to the value of manual Standard Break-Up-Time (SBUT): * 0-5 seconds (very dry) * 5-10 seconds (sec) * 10-15 seconds (moderately dry) * 15-20 seconds (normal)
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04093037
Sponsor's protocol ID: 18CH115
Other IDs: 2018-A02257-48
Acronym: LACRYMOSA
Status last verified: Sep 2020
First submitted: 16 Sep 2019
Last updated: 9 Sep 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Analysis of the Diagnostic Performance of LacryDiag, a New "All-in-one" Non-contact Analyzer of the Ocular Surface in the Dry Eye. Study LACRYMOSA
ClinicalTrials.gov ID: NCT04093037
Acronym / sponsor ID: LACRYMOSA / 18CH115
Conditions: Dry Eye
Keywords: Dry eye, LacryDiag, Fluorescein, Break-Up Time (BUT), Schirmer test, Lacrimal film, Oxford score, Meibomian Gland
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
Study start: 14 Nov 2019 (actual)
Primary completion: 27 Aug 2020 (actual)
Study completion: 27 Aug 2020 (actual)
First posted: 17 Sep 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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 80 patients divided into 4 subgroups according to the value of manual Standard Break-Up-Time (SBUT): * 0-5 seconds (very dry) * 5-10 seconds (sec) * 10-15 seconds (moderately dry) * 15-20 seconds (normal)

Arm	Type	Receives
Patient with dry eye disease	Experimental	Diagnostic Test: Time #1: Non Invasive Break-Up Time (NIBUT), Diagnostic Test: Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score, Diagnostic Test: Time #3: Standard Break-Up Time (SBUT), Diagnostic Test: Time #4: Schirmer test, Diagnostic Test: Satisfaction questionnaire to the patientPatient with dry eye disease will be included. They will have: * Time #1: LacryDiag examination without dye * Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score * Time #3: Standard Break-Up Time (SBUT) * Time #4: Schirmer test * Satisfaction questionnaire to the patient

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Affiliates or beneficiaries of social security scheme
With Dry eye of any cause, diagnosed with conventional means
Signed informed consent

Key exclusion criteria (7 listed)

Major blepharospasm
Serious illness preventing participation according to investigator
Allergy to fluorescein
Pregnant or / and breastfeeding women
Under guardianship, curatorship or safeguard of justice

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
Time #1: Non Invasive Break-Up Time (NIBUT)Also: LacryDiag, Complete diagnosis of dry eyesA LacryDiag examination without dye will be realized. All measurements are made without contact. It's calculates the Non Invasive Break-Up Time (NIBUT), Tear Meniscus (TM) height (in millimeters) and number of Meibomian Gland. These are different pictures taken with LacryDiag and analyzed.	Diagnostic test	Patient with dry eye disease
Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford scoreThe MicroInstillation of fluorescein Break-Up Time (MIBUT) will be calculated by manual MIBUT and LacryDiag MIBUT. The Oxford score will be calculated. It's used to clinically determine the severity of dry eyes with minimum score at 0 (none) and maximum score at 5 (very severity).	Diagnostic test	Patient with dry eye disease
Time #3: Standard Break-Up Time (SBUT)The Standard Break-Up Time (SBUT) with fluorescein macroinstillation will be calculated by manual SBUT and LacryDiag SBUT.	Diagnostic test	Patient with dry eye disease
Time #4: Schirmer testThe Schirmer test will be performed. It consists of applying the end of a small strip of blotting paper behind the lower eyelid and examining the strip after 5 minutes.	Diagnostic test	Patient with dry eye disease
Satisfaction questionnaire to the patientA satisfaction questionnaire to the patient will be completed at the end of the participation at the study.	Diagnostic test	Patient with dry eye disease

Primary outcome

Break-Up-Time (BUT)
Time frame: Day: 1
Comparison of Break-Up-Time (BUT) measured by 2 methods : LacryDiag Non Invasive Break-Up Time (NIBUT) and manual Standard Break-Up Time (SBUT). Measured in seconds by time#1: Non Invasive Break-Up Time (NIBUT) and time#3: Standard Break-Up Time (SBUT).

5 secondary outcomes

Standard Break-Up Time (SBUT)
Time frame: Day: 1
MicroInstillation Break-Up Time (MIBUT)
Time frame: Day: 1
Tear Meniscus (TM) height and Schirmer test
Time frame: Day: 1
Percentage loss of Meibomian Gland.
Time frame: Day: 1
Thickness (in nanometer) and regularity of lacrimal film (type)
Time frame: Day: 1

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 9 Sep 2020.
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.

Gilles THURET, MD PhD principal investigator

Centre Hospitalier Universitaire de Saint Etienne

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 7 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 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Break-Up-Time (BUT) (time frame: Day: 1). 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 NCT04093037.

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 9 Sep 2020.