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

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Disease (DED)
• Intervention / Treatment: Device: T2769

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Medical Affairs Director; Phone Number: +33473981436; Email: Florence.NOIRT@theapharma.com

Study Locations

• Bulgaria
  • Varna, Bulgaria, 9002
    • Recruiting
    • Group Practice Outpatient Clinic for Specialized Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men and women aged over 18 years,
• Able to give written informed consent prior the initiation of any procedure,
• History of dry eye syndrome for at least 3 months,
• OSDI ≥13,
• Never been treated with artificial tears or with no artificial tears at least 1 month before the enrolment, or not satisfied with current artificial tears.

Exclusion Criteria:

Systemic/non Ophthalmic Exclusion Criteria

• Known or suspected hypersensitivity to one of the components of the IMD,
• History of or active relevant systemic condition incompatible with the investigation or likely to interfere with the investigation results or the patient safety according to investigator judgment.

Specific Exclusion Criteria Regarding Childbearing Potential Women

• Pregnant or breast-feeding women,
• Childbearing potential women neither surgically sterilised nor using an adequate contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch) .

Exclusion Criteria Related to General Conditions

• Alcohol addiction and heavy smoker according to investigator's judgement,
• Unable to understand the investigation procedures or to give informed consent,
• Non-compliant (e.g., not willing to attend a visit or completing the self-questionnaire; way of life interfering with compliance),
• Participant in this investigation at the same time as another clinical investigation/study,
• Participant in this investigation within the exclusion period of a previous study/investigation with a minimum of one month,
• Participant being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee or family member of the investigation sites or of the Sponsor's company.

Exclusion criteria related to previous and concomitant treatments (medications/non-medicinal therapies/procedures)

• Participant with previous, current or anticipated prohibited listed treatment (or prohibited modification of treatment regimen).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated group; Groupe receiving T2769	Device: T2769; Preservative-free combination of trehalose, sodium hyaluronate and N-acetyl-aspartyl-glutamate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of DED signs and symptoms at 6 months (M6) according to Ocular Surface Disease Index (OSDI) score change from baseline to M6	Improvement of DED signs and symptoms at 6 months (M6) according to Ocular Surface Disease Index (OSDI) score change from baseline to M6 OSDI is a 12-item scale with total score from 0 to 100 (Mild 13-22; moderate 23-32; severe 33-100)	at baseline, at 3 months, at 6 months

Collaborators and Investigators

• Sponsor: Laboratoires Thea

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: LT2769-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No