Dry Eye Disease (DED)NCT07007702
Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients With Chronic Dry Eye Disease
An observational study of Dry Eye Disease (DED), run by Laboratoires Thea at 1 site in Austria.
Trial summary
The goal of this prospective, open, monocentric study is to evaluate the clinical efficacy of a new preservative-free combination of trehalose, sodium hyaluronate and NAAGA in 30 patients with chronic dry eye disease and associated ocular surface inflammation. 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
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 27 Jan 2025to 30 Jun 2025
- Phase
- Observational
- 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
Study population: A total of 30 patients with moderate to severe dry eye disease and associated inflammation.
Who may be able to join
- Age ≥ 18 years
- Normal ophthalmic findings except dry eye disease
- Chronic dry eye defined as longer than six months since diagnosis
- OSDI ≥ 22
- Conjunctival Hyperemia≥ Grade 3 (Efron Scale)
- Current use of topical lubricants since at least 3 months
Who cannot join
- Ophthalmic exclusion criteria
- Best far corrected visual acuity < 1/10
- Severe Dry Eye associated with:
- Eyelid malposition
- Sjogren Syndrome
- Stevens Johnson Syndrome
Show all 38Show fewer
- Corneal dystrophy
- Ocular neoplasia
- Filamentous keratitis
- Corneal neovascularisation
- Orbital radiotherapy
- Dry eye related to GVHD
- History of any of the following within last 3 months:
- Systemic treatment of dry eye
- Systemic treatment of MGD
- Isotretinoïde,
- Cyclosporine,
- Tacrolimus, Siromilus, Pimecrolimus
- Punctual plugs
- History of any of the following within previous six months:
- ocular trauma
- ocular infection, Ocular allergy
- History of any of the following within last 12 months:
- inflammatory corneal ulcer
- Herpetic eye infection
- or uveitis
- Ocular surgery
- Systemic / non ophthalmic exclusion criteria:
- Known hypersensitivity to any of the components of the medical device under investigation or other study medication
- Specific exclusion criteria for women:
- Pregnant or breast-feeding woman.
- Woman of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (i.e. hormonal contraceptives, intra-uterine device, contraceptive implant or condoms)
- Inability of patient to understand the investigation procedures and thus inability to give valid, informed consent.
- Non-compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
- Participation in another clinical study or clinical investigation at the same time as the present investigation
- Participation to the present clinical investigation during the exclusion period of another clinical study
- Patient already included once in this clinical investigation
- Patient under guardianship
Trial locations and contacts
1 site in 1 country.
Austria1 site
Universitätsklinik für Klinische Pharmakologie, Allgemeines Krankenhaus Wien
Vienna
About this study
Official title: Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation
The goal of this prospective, open, monocentric study is to evaluate the clinical efficacy of a new preservative-free combination of trehalose, sodium hyaluronate and NAAGA in 30 patients with chronic dry eye disease and associated ocular surface inflammation.
The main question it aims to answer is:
- To assess the improvement of conjunctival hyperemia as well as subjective symptoms in patients with moderate to severe dry eye.
Participants will be asked to use T2769 on a daily basis.
- 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 Glutamic Acid
| Study group | Role | What they receive |
|---|---|---|
| Group receiving T2769 | Not described Receives: Device: T2769 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with Visual Analog Scale (0-10) at week 12 - Descriptive analysis
Scores will be determined using a 100 mm VAS on which 0 means "I do not agree" and 100 means "I totally agree". The following questions will be assessed using VAS:
"I feel satisfied using this treatment" "With these eye drops, I have a feeling of freshness" "With these eye drops, I have a feeling of relief" "This product contributed to reduce my pain due to eye dryness" "This product is comfortable"
Measured: at week 12
Conjunctival hyperaemia assesment with Efron scale at week 12
Conjunctival hyperemia grading with Photographs (Efron) scale at week 12
- Descriptive analysis
- Cross table baseline vs week 12; McNemar Bowker (0) = None
- = Trace
- = Mild
- = Moderate
- = Severe
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start27 Jan 2025
- Primary completion28 Apr 2025
- Study completion30 Jun 2025
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- 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
- NCT07007702
- Sponsor's protocol ID
- LT2769-005
- Status last verified
- Sep 2025
- First submitted
- 17 Apr 2025
- Last updated
- 25 Sep 2025
- 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 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation
- ClinicalTrials.gov ID
- NCT07007702
- Acronym / sponsor ID
- LT2769-005
- Conditions
- Dry Eye Disease (DED)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 6 Jun 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, open, monocentric study is to evaluate the clinical efficacy of a new preservative-free combination of trehalose, sodium hyaluronate and NAAGA in 30 patients with chronic dry eye disease and associated ocular surface inflammation.
The main question it aims to answer is:
- To assess the improvement of conjunctival hyperemia as well as subjective symptoms in patients with moderate to severe dry eye.
Participants will be asked to use T2769 on a daily basis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group receiving T2769 | – | Device: T2769 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 30 patients with moderate to severe dry eye disease and associated inflammation.
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Normal ophthalmic findings except dry eye disease
- Chronic dry eye defined as longer than six months since diagnosis
- OSDI ≥ 22
- Conjunctival Hyperemia≥ Grade 3 (Efron Scale)
Key exclusion criteria (38 listed)
- Ophthalmic exclusion criteria
- Best far corrected visual acuity < 1/10
- Severe Dry Eye associated with:
- History of any of the following within last 3 months:
- Systemic treatment of dry eye
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 Glutamic Acid | Device | Group receiving T2769 |
Primary outcome
Patient satisfaction with Visual Analog Scale (0-10) at week 12 - Descriptive analysis
Time frame: at week 12
Scores will be determined using a 100 mm VAS on which 0 means "I do not agree" and 100 means "I totally agree". The following questions will be assessed using VAS: "I feel satisfied using this treatment" "With these eye drops, I have a feeling of freshness" "With these eye drops, I have a feeling of relief" "This product contributed to reduce my pain due to eye dryness" "This product is comfortable"
Conjunctival hyperaemia assesment with Efron scale at week 12
Time frame: week 12
Conjunctival hyperemia grading with Photographs (Efron) scale at week 12 * Descriptive analysis * Cross table baseline vs week 12; McNemar Bowker (0) = None 1. = Trace 2. = Mild 3. = Moderate 4. = Severe
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 25 Sep 2025.
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?
An observational study of Dry Eye Disease (DED), run by Laboratoires Thea at 1 site in Austria.
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 6 inclusion and 38 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 25 Sep 2025. 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 Austria. 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?
Patient satisfaction with Visual Analog Scale (0-10) at week 12 - Descriptive analysis (time frame: at week 12). The study lists 2 primary outcomes in all. 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 25 Sep 2025.