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

New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) in Dry Eye (NCT06903741) is a Phase 4 interventional studying Dry Eye Disease (DED), sponsored by Laboratoires Thea. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Men and women aged over 18 years, - Able to give written willing to sign a consent form 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. Who Should NOT Join This Trial: 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 willing to sign a consent form, - 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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).

Treatments Being Tested

DEVICE

T2769

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Group Practice Outpatient Clinic for Specialized Medical

Varna, Bulgaria

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06903741), the sponsor (Laboratoires Thea), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06903741 clinical trial studying?

Who can participate in NCT06903741?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06903741?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06903741. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06903741. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.