Dry Eye Disease (DED)NCT06903741
New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) in Dry Eye
A study testing T2769 in people with Dry Eye Disease (DED), run by Laboratoires Thea at 1 site in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- T2769
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBulgaria
- Study dates
- 21 Oct 2025to 26 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged over 18 years,
- Able to give written informed consent prior the initiation of any procedure,
- Dry eye diagnosis and/or dry eye symptoms in the last 3 months,
- OSDI >12,
- 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 cannot join
- Ophthalmic Exclusion Criteria in at least one eye •Far BCVA ≥+0.7 LogMAR (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 ETDRS letters).
- 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,
Show all 15Show fewer
- Childbearing potential women neither surgically sterilised nor using an adequate contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch).
- 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).
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Group Practice Outpatient Clinic for Specialized Medical Care in Ocular Diseases Dr. Grupchevi Ltd.
Varna, 9002
About this study
Official title: 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
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.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- T2769
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T2769Device
Preservative-free combination of trehalose, sodium hyaluronate and N-acetyl-aspartyl-glutamate
| Study group | Role | What they receive |
|---|---|---|
| Treated group | Experimental | Groupe receiving T2769 Receives: Device: T2769 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of DED signs and symptoms at 6 months (M6) according to Ocular Surface Disease Index (OSDI) score change from baseline to M6
Improvement of DED signs and symptoms at 6 months (M6) according to Ocular Surface Disease Index (OSDI) score change from baseline to M6 OSDI is a 12-item scale with total score from 0 to 100 (Mild 13-22; moderate 23-32; severe 33-100)
Measured: at baseline, at 3 months, at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start21 Oct 2025
- Primary completion26 Jul 2026
- Study completion26 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903741
- Sponsor's protocol ID
- LT2769-006
- Status last verified
- Aug 2026
- First submitted
- 21 Mar 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06903741
- Acronym / sponsor ID
- LT2769-006
- Conditions
- Dry Eye Disease (DED)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 26 Jul 2026 (actual)
- Study completion
- 26 Jul 2026 (actual)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated group | Experimental | Device: T2769Groupe receiving T2769 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged over 18 years,
- Able to give written informed consent prior the initiation of any procedure,
- Dry eye diagnosis and/or dry eye symptoms in the last 3 months,
- OSDI >12,
- 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.
Key exclusion criteria (15 listed)
- Ophthalmic Exclusion Criteria in at least one eye •Far BCVA ≥+0.7 LogMAR (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 ETDRS letters).
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T2769Preservative-free combination of trehalose, sodium hyaluronate and N-acetyl-aspartyl-glutamate | Device | Treated group |
Primary outcome
Improvement of DED signs and symptoms at 6 months (M6) according to Ocular Surface Disease Index (OSDI) score change from baseline to M6
Time frame: at baseline, at 3 months, at 6 months
Improvement of DED signs and symptoms at 6 months (M6) according to Ocular Surface Disease Index (OSDI) score change from baseline to M6 OSDI is a 12-item scale with total score from 0 to 100 (Mild 13-22; moderate 23-32; severe 33-100)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Related trials for Dry Eye Disease (DED)
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T2769 in people with Dry Eye Disease (DED), run by Laboratoires Thea at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of DED signs and symptoms at 6 months (M6) according to Ocular Surface Disease Index (OSDI) score change from baseline to M6 (time frame: at baseline, at 3 months, at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.