Dry Eye SyndromesNCT03874429

Efficacy of T2259 in DED

A study testing T2259 and Vismed multi in people with Dry Eye Syndromes, run by Laboratoires Thea at 1 site in France.

Completed

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

Trial summary

The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndromes
What is being tested?: T2259 and Vismed multi
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 1 siteFrance
Study dates: 24 Apr 2019to 25 Mar 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Main inclusion Criteria:

Signed and dated informed consent
Male or female aged from ≥ 18 years old
Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection

Main exclusion Criteria:

Far best-corrected visual acuity≤2/10
Severe Blepharitis

Trial locations and contacts

1 site in 1 country.

France1 site

C.H.N.O des XV-XX
Paris, 75012

Other trials in France

About this study

Official title: Comparison of the Performance and Safety of T2259 Versus Vismed Multi in Dry Eye Patients With Superficial Keratitis.

The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.

Conditions: Dry Eye Syndromes
Being tested: T2259, Vismed multi
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.

T2259Device
Also called Sodium Hyaluronate and Trehalose
Sodium Hyaluronate and Trehalose
Vismed multiDevice
Also called Sodium Hyaluronate
HA

Study groups in NCT03874429
Study group	Role	What they receive
T2259	Experimental	1 drop in each eye 2 to 4 times daily Receives: Device: T2259
Vismed Multi	Active comparator	1 drop in each eye 2 to 4 times daily Receives: Device: Vismed multi

What is being measured

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

Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15)
Change from baseline in the worse eye at Day 35 in Global Ocular staining (decrease of oxford score = better outcome)
Measured: Baseline and Day 35

Timeline

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

24 Apr 201925 Mar 2021

First posted14 Mar 2019
Study start24 Apr 2019
Primary completion12 Feb 2021
Study completion25 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03874429
Sponsor's protocol ID: LT2259-001
Status last verified: Jun 2022
First submitted: 12 Mar 2019
Last updated: 1 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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?

See locations

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All Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Performance and Safety of T2259 Versus Vismed Multi in Dry Eye Patients With Superficial Keratitis.
ClinicalTrials.gov ID: NCT03874429
Acronym / sponsor ID: LT2259-001
Conditions: Dry Eye Syndromes
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Laboratoires TheaIndustry (pharma, biotech, devices)
Study start: 24 Apr 2019 (actual)
Primary completion: 12 Feb 2021 (actual)
Study completion: 25 Mar 2021 (actual)
First posted: 14 Mar 2019 (actual)
Results: Posted 1 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
T2259	Experimental	Device: T22591 drop in each eye 2 to 4 times daily
Vismed Multi	Active comparator	Device: Vismed multi1 drop in each eye 2 to 4 times daily

Who may qualify

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

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
T2259Also: Sodium Hyaluronate and TrehaloseSodium Hyaluronate and Trehalose	Device	T2259
Vismed multiAlso: Sodium HyaluronateHA	Device	Vismed Multi

Primary outcome

Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15)
Time frame: Baseline and Day 35
Change from baseline in the worse eye at Day 35 in Global Ocular staining (decrease of oxford score = better outcome)

Results and safety

Results posted to the registry on 1 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T2259	50	44
Vismed Multi	51	46

Primary outcome: Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15)

Time frame: Baseline and Day 35. Mean (Standard Deviation). Unit: score on a scale

Measure	T2259 n = 42	Vismed Multi n = 42
Value	-1.45 (1.88)	-1.79 (1.68)

T2259 vs Vismed Multi: Mean Difference (Net): 0.31 (95% CI -0.42 to 1.05), ANCOVA

Population analysed: PP population

Adverse events

Time frame: 15 weeks from D-10 to D84 (±7 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T2259	0 of 50 (0%)	4 of 50 (8%)	0 of 50
Vismed Multi	1 of 51 (2%)	0 of 51 (0%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dry Eye Syndromes

Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
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Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
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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.

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

Questions about this trial

What is this clinical trial studying?

A study testing T2259 and Vismed multi in people with Dry Eye Syndromes, run by Laboratoires Thea at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 1 Nov 2023. 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?

Yes. Results are posted in the registry (first posted 1 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15) (time frame: Baseline and Day 35). 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 NCT03874429.

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 1 Nov 2023.