Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome

Thea Pharma

Status

Enrolling

Conditions

Dry Eye

Treatments

Device: Vismed® Multi

Device: T2769

Study type

Interventional

Funder types

Industry

Identifiers

NCT05965778

LT2769-002

Details and patient eligibility

About

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.

Enrollment

226 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.