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New treatment option for Dry Eye Disease (DED)
Official title New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) in Dry Eye
ClinicalTrials.gov ID: NCT06903741
What this study is testing
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Pregnant or breast-feeding women,
- Childbearing potential women neither surgically sterilised nor using an adequate contraception (oral contraceptive, intra-uterine device...
- Alcohol addiction and heavy smoker according to investigator's judgement,
See the full eligibility 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.
- 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...
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Varna, Bulgaria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Varna, Bulgaria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.