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

Last updated: November 14, 2025
Sponsor: Laboratoires Thea
Overall Status: Active - Recruiting

Phase

4

Condition

Dry Eye Disease

Sjogren's Syndrome

Eyelid Inflammation

Treatment

T2769

Clinical Study ID

NCT06903741
LT2769-006
  • Ages > 18
  • All Genders

Study 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

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 1month before the enrolment, or not satisfied with current artificial tears.

Exclusion

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 investigationor likely to interfere with the investigation results or the patient safetyaccording to investigator judgment.

Specific Exclusion Criteria Regarding Childbearing Potential Women

  • Pregnant or breast-feeding women,

  • Childbearing potential women neither surgically sterilised nor using an adequatecontraception (oral contraceptive, intra-uterine device, subcutaneous contraceptiveimplant, 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 theself-questionnaire; way of life interfering with compliance),

  • Participant in this investigation at the same time as another clinicalinvestigation/study,

  • Participant in this investigation within the exclusion period of a previousstudy/investigation with a minimum of one month,

  • Participant being institutionalized because of legal or regulatory order, inmate ofpsychiatric wards, prison or state institutions, or employee or family member of theinvestigation 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 Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: T2769
Phase: 4
Study Start date:
October 21, 2025
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Group Practice Outpatient Clinic for Specialized Medical

    Varna 726050, 9002
    Bulgaria

    Active - Recruiting

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