Dry EyeNCT05965778
Performance and Safety of T2769 in DED
A study testing T2769 and Vismed® Multi in people with Dry Eye, run by Laboratoires Thea at 1 site in France.
Trial summary
To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total ocular surface staining (Oxford score) after 35 days of treatment. To evaluate the performance and safety of T2769 versus Vismed® Multi. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- T2769 and Vismed® Multi
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2023to 15 Aug 2024
- 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
Who may be able to join
- Informed consent signed and dated (obtained prior to initiating any procedures).
- Patient aged ≥18 years old.
- Known dry eye syndrome requiring artificial tears for at least the last 3 months prior to screening visit.
- Surface Disease Index (OSDI) Score ≥ 23.
- Ocular discomfort evaluated by VAS ≥ 40 mm.
Who cannot join
- Far best-corrected visual acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 (ETDRS) letters Early Treatment Diabetic Retinopathy Study).
- Severe blepharitis according to the judgment of the investigator
- Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome
To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total ocular surface staining (Oxford score) after 35 days of treatment.
To evaluate the performance and safety of T2769 versus Vismed® Multi.
- Conditions
- Dry Eye
- Being tested
- T2769, 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.
T2769Device
T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.
Vismed® MultiDevice
Hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| T2769 | Experimental | 1 drop in each eye, 3 to 6 times daily Receives: Device: T2769 |
| Vismed® Multi | Active comparator | 1 drop in each eye, 3 to 6 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 : Minimum 0- Maximum 15)
Change from baseline (Day 1) in the worse eye at Day 36 in Global Ocular staining (decrease of oxford score = better outcome)
Measured: Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start2 Oct 2023
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
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 EyeStudies 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
- Model description
- Change from baseline in the study eye at Day 36 in Global Ocular staining (decrease of oxford score = better outcome)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frédéric CHIAMBARETTA, Prof., Principal investigator, Individual Practice for Specialized Ophthalmology Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965778
- Sponsor's protocol ID
- LT2769-002
- Status last verified
- Dec 2025
- First submitted
- 20 Jul 2023
- Last updated
- 23 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT05965778
- Acronym / sponsor ID
- LT2769-002
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Posted 23 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total ocular surface staining (Oxford score) after 35 days of treatment.
To evaluate the performance and safety of T2769 versus Vismed® Multi.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Change from baseline in the study eye at Day 36 in Global Ocular staining (decrease of oxford score = better outcome)
| Arm | Type | Receives |
|---|---|---|
| T2769 | Experimental | Device: T27691 drop in each eye, 3 to 6 times daily |
| Vismed® Multi | Active comparator | Device: Vismed® Multi1 drop in each eye, 3 to 6 times daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent signed and dated (obtained prior to initiating any procedures).
- Patient aged ≥18 years old.
- Known dry eye syndrome requiring artificial tears for at least the last 3 months prior to screening visit.
- Surface Disease Index (OSDI) Score ≥ 23.
- Ocular discomfort evaluated by VAS ≥ 40 mm.
Key exclusion criteria (3 listed)
- Far best-corrected visual acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 (ETDRS) letters Early Treatment Diabetic Retinopathy Study).
- Severe blepharitis according to the judgment of the investigator
- Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.
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 |
|---|---|---|
| T2769T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle. | Device | T2769 |
| Vismed® MultiHyaluronic acid | Device | Vismed® Multi |
Primary outcome
Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : Minimum 0- Maximum 15)
Time frame: Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36
Change from baseline (Day 1) in the worse eye at Day 36 in Global Ocular staining (decrease of oxford score = better outcome)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dry Eye
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
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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.
Frédéric CHIAMBARETTA, Prof. principal investigator
Individual Practice for Specialized Ophthalmology Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T2769 and Vismed® Multi in people with Dry Eye, 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?
The sponsor lists 5 inclusion and 3 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 23 Jan 2026. 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 23 Jan 2026). 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 : Minimum 0- Maximum 15) (time frame: Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2026.