NCT06903741 New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) in Dry Eye
| NCT ID | NCT06903741 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Laboratoires Thea |
| Condition | Dry Eye Disease (DED) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-10-21 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2025-10-21 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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: 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06903741 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dry Eye Disease (DED). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06903741 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06903741 currently recruiting?
Yes, NCT06903741 is actively recruiting participants. Contact the research team at Florence.NOIRT@theapharma.com for enrollment information.
Where is the NCT06903741 trial being conducted?
This trial is being conducted at Varna, Bulgaria.
Who is sponsoring the NCT06903741 clinical trial?
NCT06903741 is sponsored by Laboratoires Thea. The trial plans to enroll 30 participants.