Comparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome.
- Conditions
- Dry Eye Syndrome
- Interventions
- Device: Hylo-Forte®Device: T2769
- Registration Number
- NCT06375499
- Lead Sponsor
- Laboratoires Thea
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hylo-Forte® Hylo-Forte® Hyaluronic acid Route of administration: topical, ocular use T2769 T2769 Hyaluronic acid, Trehalose, Naaga Route of administration: topical, ocular use
- Primary Outcome Measures
Name Time Method To demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of total ocular surface staining (Oxford score). Oxford 0-15 grading scheme: is assessed at Day 1, Day 15 and Day 36 The primary endpoint is the change from baseline (Day 1) in total ocular surface staining grade according to Oxford Scale 0-15 grading scheme at D36 in the study eye. Minimum value is 0 (better case) and maximum value is 15 (worse case)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
OFTEX, s.r.o.
🇨🇿Praha, Czech Republic
Axon Clinical, s.r.o.
🇨🇿Praha, Czech Republic
Ganglion Medical Center
🇭🇺Pécs, Baranya, Hungary
Ermellek Egeszsegcentrum
🇭🇺Létavértes, HB, Hungary