---
title: Performance and Safety of T2769 in DED
nct_id: NCT05965778
overall_status: COMPLETED
phase: NA
sponsor: Laboratoires Thea
study_type: INTERVENTIONAL
primary_condition: Dry Eye
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05965778.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05965778"
ct_last_update_post_date: 2026-01-23
last_seen_at: "2026-05-12T07:33:45.284Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Performance and Safety of T2769 in DED

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

**NCT ID:** [NCT05965778](https://clinicaltrials.gov/study/NCT05965778)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 251
- **Lead Sponsor:** Laboratoires Thea
- **Conditions:** Dry Eye
- **Start Date:** 2023-10-02
- **Completion Date:** 2024-08-15
- **CT.gov Last Update:** 2026-01-23

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **T2769** (EXPERIMENTAL) — 1 drop in each eye, 3 to 6 times daily
- **Vismed® Multi** (ACTIVE_COMPARATOR) — 1 drop in each eye, 3 to 6 times daily

## Interventions

- **T2769** (DEVICE) — T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.
- **Vismed® Multi** (DEVICE) — Hyaluronic acid

## Primary Outcomes

- **Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : Minimum 0- Maximum 15)** _(time frame: 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)

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.gabriel-montpied university hospital|clermont-ferrand||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05965778.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05965778*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*