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New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) in Dry Eye

NCT06903741 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-18

No results posted yet for this study

Summary

The goal of this prospective, non-randomized, non-comparative, monocentric PMCF study is to assess the performance of a new preservative-free combination of trehalose, sodium hyaluronate and NAAGA on DED at 6 months in 30 patients having dry eye disease.

The main questions it aims to answer are:

* To assess the performance and safety of T2769 at 3 months and 6 months.
* To assess patient compliance to therapy.
* To assess the occurrence of dry eye flares. Participants will be asked to use T2769 on a daily basis and complete a self-questionnaire throughout the study.

Conditions

  • Dry Eye Disease (DED)

Interventions

DEVICE

T2769

Preservative-free combination of trehalose, sodium hyaluronate and N-acetyl-aspartyl-glutamate

Sponsors & Collaborators

  • Laboratoires Thea

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-21
Primary Completion
2026-05-31
Completion
2026-06-30

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06903741 on ClinicalTrials.gov