Comparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome.

Thea Pharma

Status: Completed

Conditions: Dry Eye Syndrome

Treatments: Device: T2769; Device: Hylo-Forte®

Study type: Interventional

Funder types: Industry

Identifiers

NCT06375499

LT2769-004

Details and patient eligibility

About

The objective is to demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of the change from baseline (D1) in total ocular surface staining score assessed on Oxford 0-15 scale, in the study eye at the D36 visit.

The investigation is defined as a post-market stage. The clinical investigation design is confirmatory.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria (At Screening visit):

• Informed consent signed and dated (obtained prior to initiating any procedures).
• Patient aged ≥18 years old.
• Persistence of dry eye syndrome, despite artificial tears use in the previous month prior to the screening visit

Main Exclusion Criteria (At both Screening and Randomisation visits):

• Far Best-Corrected Visual Acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 letters Early Treatment Diabetic Retinopathy Study (ETDRS)).
• Patient with previous or current ophthalmic condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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77 participants in 2 patient groups

T2769

Experimental group

Description:

Hyaluronic acid, Trehalose, Naaga Route of administration: topical, ocular use

Treatment:

Device: T2769

Hylo-Forte®

Active Comparator group

Description:

Hyaluronic acid Route of administration: topical, ocular use

Treatment:

Device: Hylo-Forte®