Comparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome.
Not Applicable
Not yet recruiting
- Conditions
- Dry Eye Syndrome
- Registration Number
- NCT06375499
- Lead Sponsor
- Laboratoires Thea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Main Inclusion Criteria (At Screening visit):<br><br> - Informed consent signed and dated (obtained prior to initiating any procedures).<br><br> - Patient aged =18 years old.<br><br> - Persistence of dry eye syndrome, despite artificial tears use in the previous month<br> prior to the screening visit<br><br>Main Exclusion Criteria (At both Screening and Randomisation visits):<br><br> - Far Best-Corrected Visual Acuity (BCVA) =+0.7 LogMar (e.g., =0.2 in decimal value or<br> =20/100 Snellen equivalent or =50 letters Early Treatment Diabetic Retinopathy Study<br> (ETDRS)).<br><br> - Patient with previous or current ophthalmic condition
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- 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).
- Secondary Outcome Measures
Name Time Method