Dry Eye
Conditions
Brief 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.
Interventions
DEVICET2769
T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.
DEVICEVismed® Multi
Hyaluronic acid
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Change from baseline in the study eye at Day 36 in Global Ocular staining (decrease of oxford score = better outcome)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : Minimum 0- Maximum 15) | 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) |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORFrédéric CHIAMBARETTA, Prof.
Individual Practice for Specialized Ophthalmology Care
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 101 Participants |
| Age, Categorical Between 18 and 65 years | 150 Participants |
| Age, Continuous | 59.4 years STANDARD_DEVIATION 14.34 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Austria | 30 Participants |
| Region of Enrollment France | 0 Participants |
| Region of Enrollment Greece | 27 Participants |
| Region of Enrollment Hungary | 11 Participants |
| Region of Enrollment Israel | 32 Participants |
| Region of Enrollment Italy | 17 Participants |
| Region of Enrollment Slovakia | 17 Participants |
| Region of Enrollment Spain | 89 Participants |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 125 | 0 / 126 |
| other Total, other adverse events | 0 / 125 | 0 / 126 |
| serious Total, serious adverse events | 0 / 125 | 2 / 126 |
Outcome results
None listed