N/A
N=251
Performance and Safety of T2769 in DED
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT05965778 ↗Enrolled (actual)
251
Serious AEs
0.8%
Results posted
Jan 2026
Primary outcome: Primary: Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : Minimum 0- Maximum 15) — -2.3; -2.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- T2769 (Device); Vismed® Multi (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laboratoires Thea
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : Minimum 0- Maximum 15) |
-2.3; -2.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05965778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.