Status:
RECRUITING
New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) in Dry Eye
Lead Sponsor:
Laboratoires Thea
Conditions:
Dry Eye Disease (DED)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06903741
Start Date
October 21 2025
End Date
June 1 2026
Last Update
November 18 2025
Active Locations (1)
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1
Group Practice Outpatient Clinic for Specialized Medical
Varna, Bulgaria, 9002