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

Not Applicable

Recruiting

• Conditions: Dry Eye
• Interventions: Device: T2769; Device: Vismed® Multi

• Registration Number: NCT05965778
• Lead Sponsor: Laboratoires Thea

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-07-27
• Study First Posted: 2023-07-28
• Study Start: 2023-10-02
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-29
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 226

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T2769	T2769	-
Vismed® Multi	Vismed® Multi	-

Primary Outcome Measures

Name	Time	Method
Change from baseline (Day 1) in total ocular surface staining grade according to Oxford 0-15 grading scheme.	Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36	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)

Trial Locations

Locations (1)

Gabriel-Montpied University Hospital; 🇫🇷 Clermont-Ferrand, France