Performance and Safety of T2769 in DED

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Device: T2769; Device: Vismed® Multi

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Gabriel-Montpied University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T2769; 1 drop in each eye, 3 to 6 times daily	Device: T2769; T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.
Active Comparator: Vismed® Multi; 1 drop in each eye, 3 to 6 times daily	Device: Vismed® Multi; Hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : Minimum 0- Maximum 15)	Change from baseline (Day 1) in the worse eye at Day 36 in Global Ocular staining (decrease of oxford score = better outcome)	Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36

Collaborators and Investigators

• Sponsor: Laboratoires Thea
• Investigators: Principal Investigator: Frédéric CHIAMBARETTA, Prof., Individual Practice for Specialized Ophthalmology Care

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Actual): August 15, 2024
• Study Completion (Actual): August 15, 2024

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: LT2769-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No