Performance and Safety of T2769 in DED

NCT05965778 | Completed Results

• 1 other identifier: LT2769-002
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

T2769

EXPERIMENTAL

1 drop in each eye, 3 to 6 times daily

Device: T2769

Vismed® Multi

ACTIVE COMPARATOR

1 drop in each eye, 3 to 6 times daily

Device: Vismed® Multi

Interventions

T2769 DEVICE

T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.

T2769

Vismed® Multi DEVICE

Hyaluronic acid

Vismed® Multi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratoires Thea: lead

Study Sites (1)

Gabriel-Montpied University Hospital

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Corentin Le Camus
• Organization: Laboratoires Thea

corentin.lecamus@theapharma.com

0680382020

Study Officials

• Frédéric CHIAMBARETTA, Prof.

  Individual Practice for Specialized Ophthalmology Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Change from baseline in the study eye at Day 36 in Global Ocular staining (decrease of oxford score = better outcome)

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: October 2, 2023
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: January 23, 2026
• Results First Posted: January 23, 2026

Record last verified: 2025-12

Locations

FR (1)