NCT06903741

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

Effect of a New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) on Dry Eye Disease and Patient Quality of Life

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Laboratoires Thea · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	T2769	Preservative-free combination of trehalose, sodium hyaluronate and N-acetyl-aspartyl-glutamate

Timeline

• Start date: 2025-10-21
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2025-04-01
• Last updated: 2025-11-18

Locations

1 site across 1 country: Bulgaria