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

NCT ID: NCT06903741

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-21
• Study Completion Date: 2026-06-30

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treated group

Groupe receiving T2769

Group Type: EXPERIMENTAL

T2769

Intervention Type: DEVICE

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

Interventions

T2769

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

Intervention Type: DEVICE

Eligibility Criteria

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

• 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 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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoires Thea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Group Practice Outpatient Clinic for Specialized Medical

Varna, , Bulgaria

Site Status: RECRUITING

Countries

Bulgaria

Central Contacts

Medical Affairs Director

Role: CONTACT

Florence.NOIRT@theapharma.com

+33473981436

Other Identifiers

LT2769-006

Identifier Type: -

Identifier Source: org_study_id