Last reviewed · How we verify

NCT05965778

Performance and Safety of T2769 in DED

Completed NA Results posted Last updated 23 January 2026
What this trial tests

NA trial testing T2769 in Dry Eye in 251 participants. Completed in 15 August 2024.

Timeline
2 October 2023
Primary endpoint
15 August 2024
15 August 2024

Quick facts

Lead sponsorLaboratoires Thea
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment251
Start date2 October 2023
Primary completion15 August 2024
Estimated completion15 August 2024
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Laboratoires Thea — full company profile →

Who can join

18 and older, any sex, with Dry Eye. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : Minimum 0- Maximum 15) Primary · Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36

Change from baseline (Day 1) in the worse eye at Day 36 in Global Ocular staining (decrease of oxford score = better outcome)

GroupValue95% CI
T2769-2.3± 1.99
Vismed® Multi-2.1± 2.08

Adverse events — posted to ClinicalTrials.gov

Time frame: 7 weeks from D-10 to D36 (+3 days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

T2769
Serious: 0/125 (0%)
Deaths: 0/125
Vismed® Multi
Serious: 2/126 (2%)
Deaths: 0/126

Serious adverse events (2 terms)

ReactionSystemT2769Vismed® Multi
Limb fractureInjury, poisoning and procedural complications
haematuriaRenal and urinary disorders

Most-reported serious reactions: Limb fracture, haematuria.

Data from ClinicalTrials.gov NCT05965778 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of T2769

Trials testing the same drug.

Other recruiting trials for Dry Eye

Currently open trials in the same condition.

Other Laboratoires Thea trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05965778.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing