Dry Eye Disease (DED)Phase 4NCT07245836
Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation
A Phase 4 study testing Thealoz Total® Eye Drops, Laboratoires Thea, Clermont Ferrand, France in people with Dry Eye Disease (DED), run by Medical University of Vienna at 1 site in Austria.
Trial summary
Dry eye disease (DED) is a highly prevalent ocular condition and induces a significant burden to the affected patients. Regardless of the underlying etiology, DED is associated with increased inflammation of the entire ocular surface including the adnexa, conjunctiva and cornea. 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?
- Thealoz Total® Eye Drops, Laboratoires Thea, Clermont Ferrand, France
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 20 Jan 2025to 6 Jul 2025
- Phase
- Phase 4
- 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
- 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
- Stevens Johnson Syndrome
- Corneal dystrophy
Show all 31Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna, Austria
Vienna, State of Vienna, 1090
About this study
Dry eye disease (DED) is a highly prevalent ocular condition and induces a significant burden to the affected patients. Regardless of the underlying etiology, DED is associated with increased inflammation of the entire ocular surface including the adnexa, conjunctiva and cornea. As such, there is evidence from in vitro, animal and clinical studies that this inflammatory response of the ocular surface plays a pathophysiological key role in the development of DED. The Dry Eye Workshop 2007 (DEWS) therefore suggests beside of restoring the tear film by administering topical lubricants, breaking the vicious circle of inflammation is an important mainstay of therapy in patients with DED. Recently, a new medical device (Thealoz Total® eye drops) has been introduced for the treatment DED. Thealoz Total® eye drops are based on hyaluronic acid and exert their main action by lubricating the ocular surface. Further, this new formulation offers several advantages that make them potentially interesting to reduce DED related symptoms. First, the formulation is preservative-free, which is of special importance in patients with DED, since it has been shown that preservatives are detrimental for the ocular surface. thereby reducing signs and symptoms related to DED. Secondly, in addition to the lubricating effect of hyaluronic acid, Thealoz Total eye drops also contain trehalose, which exerts osmoprotetive effects and N-Acetyl Aspartyl Glutamic Acid (NAAGA). NAAGA is an amino conjugated dipeptide with anti-inflammatory properties. Thus, it is reasonable to hypothesize that Thealoz total eye drops are also capable of reducing ocular surface inflammation. The aim of the present study is to investigate whether topical administration with Thealoz Total® improves ocular surface inflammation as well as clinical signs and symptoms associated with DED.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Thealoz Total® Eye Drops, Laboratoires Thea, Clermont Ferrand, France
- Keywords
- Dry eye disease (DED)
- 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.
Thealoz Total® Eye Drops, Laboratoires Thea, Clermont Ferrand, FranceDrug
topical lubrication
| Study group | Role | What they receive |
|---|---|---|
| Thealoz Total® eye drops | Experimental | Thealoz Total® eye drops; 3-6 Drops per day for 12 weeks Receives: Drug: Thealoz Total® Eye Drops, Laboratoires Thea, Clermont Ferrand, France |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction assessed by a VAS
Patient satisfaction assessed by a Visual Analogue Scale (VAS) (min 0 - max 100)
The VAS consists of a 10cm line, with two end points representing 0 ('no symptoms') and 100 ('max symptoms')
Measured: week 12
Conjunctival hyperemia grading with Photographs (Efron) scale at week 12
Conjunctival hyperemia grading with Photographs (Efron) scale at week 12
The Efron Scale is a clinical grading scale used to assess conjunctival hyperemia.
It provides a standardized visual grading from 0 to 4 Grade 0 = normal Grade 1 = trace / very mild Grade 2 = mild to moderate Grade 3 = moderate to severe Grade 4 = severe
Measured: week 12
Secondary outcomes (9)
Changes from baseline in conjunctival hyperemia grading with photographs (Efron) scale
Changes from baseline in conjunctival hyperemia grading with photographs (Efron) scale
The Efron Scale is a clinical grading scale used to assess conjunctival hyperemia.
It provides a standardized visual grading from 0 to 4 Grade 0 = normal Grade 1 = trace / very mild Grade 2 = mild to moderate Grade 3 = moderate to severe Grade 4 = severe
Measured: week 6 and 12
Changes from baseline in corneal fluorescein staining according to the Oxford Scale
Changes from baseline in corneal fluorescein staining according to the Oxford Scale
The Oxford Scale is a standardized grading system corneal staining after fluorescein dye application. It indicates the level of epithelial damage or ocular surface compromise.
The grading runs from 0 to 5, based on a set of reference panels with dots representing staining patterns.
Grade 0 = none (no staining) Grade 1 = trace (minimal staining, very few punctate dots) Grade 2 = mild (slightly more numerous dots) Grade 3 = moderate (obvious punctate staining, more confluent areas) Grade 4 = marked (extensive staining, coalescent areas) Grade 5 = severe (dense, widespread staining, severe epithelial damage)
Measured: week 6 and 12
Changes from baseline in Tear Break Up Time (BUT) with Minims- Fluorescein Sodium 2,0%
Changes from baseline in Tear Break Up Time (BUT) with Minims- Fluorescein Sodium 2,0%
Measured: week 6 and 12
Changes from baseline in Schirmer I test using Schirmer paper strips
Changes from baseline in Schirmer I test using Schirmer paper strips
Measured: week 6 and 12
Changes from baseline in conjunctival hyperaemia assessment using Mc Monnies photographic scale
Changes from baseline in conjunctival hyperaemia assessment using Mc Monnies photographic scale
The McMonnies Photographic Scale is a clinical grading system for bulbar conjunctival hyperemia.
It uses a series of standardized photographs of eyes with increasing levels of redness.
Clinicians compare the patient's eye to these photographs and assign a grade.
The scale typically ranges from 0 to 5:
0 = none (normal, no redness)
- = trace (very mild hyperemia)
- = mild
- = moderate
- = marked
- = severe (intense hyperemia with engorged vessels)
Measured: week 6 and 12
Changes from baseline in symptoms using the OSDI questionnaire
Changes from baseline in symptoms using the Ocular Surface Disease Index (OSDI) questionnaire
It contains 12 questions, divided into three domains, every qestion has 0-4 points:
- Ocular symptoms
- Vision-related function
- Environmental triggers
Interpretation of scores:
0-12 = normal 13-22 = mild dry eye 23-32 = moderate dry eye 33-100 = severe dry eye
Not every patient will necessarily answer all 12 questions. To account for this, the OSDI uses a normalization formula:
- Add together all the scores from the answered questions.
- Multiply this sum by 25 (this scales the score to a 0-100 range).
- Divide the result by the number of questions answered.
Measured: week 6 and 12
Changes from baseline in symptoms within the last 48 hours
Changes from baseline in symptoms within the last 48 hours
Patient will be asked: "How do you judge the severity of your following ocular symptoms within the last 48 hours?"
The severity of the following ocular symptoms will be assessed at each visit: burning/irritation, stinging/eye pain, light sensitivity, itching/pruritus, eye dryness feeling, tearing, foreign body sensation as follows:
0 = Absent
- = Mild, present but not disturbing
- = Moderate, disturbing, but not limiting with daily activities
- = Severe, very distressing and interfering with daily activities The ocular symptoms will be assessed in global for both eyes at each visit. The value at Visit 1 will be the baseline value.
Questions are:
Burning/irritation Burning/pain Light sensitivity (photophobia) Itching Sensation of dryness in the eyes Tearing (watery eyes) Foreign body sensation
Measured: week 6 and 12
Changes from baseline in tear proteomics and lipidomics
Changes from baseline in tear proteomics and lipidomics
Tear film samples will be collected on week 1 and week 12 by Schirmer-I-Test. Samples will be extracted and and measured in an untargeted fashion.
Samples will be stored at -80°C until time of analysis and will be discarded after analysis.
Measured: week 12
Patient satisfaction assessed by a VAS
Patient satisfaction assessed by a Visual Analogue Scale (VAS)
The VAS consists of a 10cm line, with two end points representing 0 ('minimum') and 100 ('maximum')
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 posted24 Nov 2025
- Study start20 Jan 2025
- Primary completion3 Jun 2025
- Study completion6 Jul 2025
Why it stopped: This study was not halted prematurely. This record represents a duplicate entry and has therefore been withdrawn. The correct and complete study information can be found under identifier NCT07007702.
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.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doreen Schmidl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245836
- Sponsor's protocol ID
- LT2769-005
- Status last verified
- May 2026
- First submitted
- 22 Sep 2025
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. 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
- NCT07245836
- Acronym / sponsor ID
- LT2769-005
- Conditions
- Dry Eye Disease (DED)
- Keywords
- Dry eye disease (DED)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was not halted prematurely. This record represents a duplicate entry and has therefore been withdrawn. The correct and complete study information can be found under identifier NCT07007702.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 6 Jul 2025 (actual)
- First posted
- 24 Nov 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.
Dry eye disease (DED) is a highly prevalent ocular condition and induces a significant burden to the affected patients. Regardless of the underlying etiology, DED is associated with increased inflammation of the entire ocular surface including the adnexa, conjunctiva and cornea. As such, there is evidence from in vitro, animal and clinical studies that this inflammatory response of the ocular surface plays a pathophysiological key role in the development of DED. The Dry Eye Workshop 2007 (DEWS) therefore suggests beside of restoring the tear film by administering topical lubricants, breaking the vicious circle of inflammation is an important mainstay of therapy in patients with DED. Recently, a new medical device (Thealoz Total® eye drops) has been introduced for the treatment DED. Thealoz Total® eye drops are based on hyaluronic acid and exert their main action by lubricating the ocular surface. Further, this new formulation offers several advantages that make them potentially interesting to reduce DED related symptoms. First, the formulation is preservative-free, which is of special importance in patients with DED, since it has been shown that preservatives are detrimental for the ocular surface. thereby reducing signs and symptoms related to DED. Secondly, in addition to the lubricating effect of hyaluronic acid, Thealoz Total eye drops also contain trehalose, which exerts osmoprotetive effects and N-Acetyl Aspartyl Glutamic Acid (NAAGA). NAAGA is an amino conjugated dipeptide with anti-inflammatory properties. Thus, it is reasonable to hypothesize that Thealoz total eye drops are also capable of reducing ocular surface inflammation. The aim of the present study is to investigate whether topical administration with Thealoz Total® improves ocular surface inflammation as well as clinical signs and symptoms associated with DED.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thealoz Total® eye drops | Experimental | Drug: Thealoz Total® Eye Drops, Laboratoires Thea, Clermont Ferrand, FranceThealoz Total® eye drops; 3-6 Drops per day for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 (31 listed)
- Ophthalmic exclusion criteria
- Best far corrected visual acuity < 1/10
- Eyelid malposition
- Stevens Johnson Syndrome
- Corneal dystrophy
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 |
|---|---|---|
| Thealoz Total® Eye Drops, Laboratoires Thea, Clermont Ferrand, Francetopical lubrication | Drug | Thealoz Total® eye drops |
Primary outcome
Patient satisfaction assessed by a VAS
Time frame: week 12
Patient satisfaction assessed by a Visual Analogue Scale (VAS) (min 0 - max 100) The VAS consists of a 10cm line, with two end points representing 0 ('no symptoms') and 100 ('max symptoms')
Conjunctival hyperemia grading with Photographs (Efron) scale at week 12
Time frame: week 12
Conjunctival hyperemia grading with Photographs (Efron) scale at week 12 The Efron Scale is a clinical grading scale used to assess conjunctival hyperemia. It provides a standardized visual grading from 0 to 4 Grade 0 = normal Grade 1 = trace / very mild Grade 2 = mild to moderate Grade 3 = moderate to severe Grade 4 = severe
9 secondary outcomes
Changes from baseline in conjunctival hyperemia grading with photographs (Efron) scale
Time frame: week 6 and 12
Changes from baseline in corneal fluorescein staining according to the Oxford Scale
Time frame: week 6 and 12
Changes from baseline in Tear Break Up Time (BUT) with Minims- Fluorescein Sodium 2,0%
Time frame: week 6 and 12
Changes from baseline in Schirmer I test using Schirmer paper strips
Time frame: week 6 and 12
Changes from baseline in conjunctival hyperaemia assessment using Mc Monnies photographic scale
Time frame: week 6 and 12
Changes from baseline in symptoms using the OSDI questionnaire
Time frame: week 6 and 12
Changes from baseline in symptoms within the last 48 hours
Time frame: week 6 and 12
Changes from baseline in tear proteomics and lipidomics
Time frame: week 12
Patient satisfaction assessed by a VAS
Time frame: week 12
Results and safety
The study was stopped early (reason given: This study was not halted prematurely. This record represents a duplicate entry and has therefore been withdrawn. The correct and complete study information can be found under identifier NCT07007702.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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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 Phase 4 study testing Thealoz Total® Eye Drops, Laboratoires Thea, Clermont Ferrand, France in people with Dry Eye Disease (DED), run by Medical University of Vienna 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 31 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: stopped early, as of the sponsor's last update on 8 May 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study was not halted prematurely. This record represents a duplicate entry and has therefore been withdrawn. The correct and complete study information can be found under identifier NCT07007702.). Results are not available in the source record.
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 assessed by a VAS (time frame: 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 8 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.