N/A
Completed N=74
Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome.
Source: ClinicalTrials.gov NCT06375499 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: To Demonstrate the Non-inferiority of T2769 Compared to Hylo-Forte® in Terms of Total Ocular Surface Staining (Oxford Score). — -1.3; -1.2 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Demonstrate the Non-inferiority of T2769 Compared to Hylo-Forte® in Terms of Total Ocular Surface Staining (Oxford Score). |
-1.3; -1.2 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT06375499). 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. Informational only — not medical advice.