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

NCT06903741 | Recruiting Phase 4

• 1 other identifier: LT2769-006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treated group

EXPERIMENTAL

Groupe receiving T2769

Device: T2769

Interventions

T2769 DEVICE

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

Treated group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Laboratoires Thea: lead

Study Sites (1)

Group Practice Outpatient Clinic for Specialized Medical

Varna, 9002, Bulgaria

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Medical Affairs Director

CONTACT

+33473981436; Florence.NOIRT@theapharma.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: T2769

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 1, 2025
• Study Start: October 21, 2025
• Primary Completion: May 1, 2026
• Study Completion: June 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

BU (1)