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NCT05965778 Clinical Trial

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

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05965778
Other study ID # LT2769-002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 2, 2023
Est. completion date August 2024

Study information
Verified date July 2023
Source Laboratoires Thea
Contact Corentin LE CAMUS
Phone +33473981436
Email Corentin.LECAMUS@theapharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 226
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• T2769
T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.
• Vismed® Multi
Hyaluronic acid

Locations
Country Name City State
France Gabriel-Montpied University Hospital Clermont-Ferrand

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires Thea

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline (Day 1) in total ocular surface staining grade according to Oxford 0-15 grading scheme. The primary endpoint is the change from baseline (Day 1) in total ocular surface staining grade according to Oxford Scale (Oxford Scheme) 0-15 grading scheme at D36 in the study eye. Minimum value is 0 (better outcome) and maximum value is 15 (worse outcome) Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36
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