Dry Eye Disease (DED)NCT07234318
A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study
An observational study of Dry Eye Disease (DED), run by Laboratoires Thea at 1 site in Austria.
Trial summary
The FOCUS study aims to evaluate the clinical efficacy of 0.1% cyclosporine eye drops solution (Vevizye®, Laboratoires THEA) in patients with moderate to severe dry eye disease characterized by 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?
- Cyclosporin
- How many people
- 25 participants
- Where
- 1 siteAustria
- Study dates
- 20 Jan 2026to 1 Jun 2026
- 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: Patients recruited in University of Vienna
Who may be able to join
- Age ≥ 18 years
- No patients with other ophthalmic diseases than DED
- Chronic dry eye defined as longer than six months since diagnosis
- OSDI score > 22
- Conjunctival Hyperemia ≥ Grade 3 (Efron Scale)
- Current use of tear substitutes for at least 3 months not to be considered as sufficient by the investigator/treating physician
- Need to add cyclosporine eye drops to tear substitutes as judged by the investigator/treating physician
Who cannot join
- Ophthalmic exclusion criteria
- Far best corrected visual acuity < 1/10
- Severe Dry Eye associated with:
- Eyelid malposition
- Stevens Johnson Syndrome
- Corneal dystrophy
Show all 37Show fewer
- Ocular neoplasia
- Filamentous keratitis
- Corneal neovascularisation
- Orbital radiotherapy
- Dry eye related to Graft Versus Host Disease (GVHD)
- History of any of the following within last 3 months:
- Systemic treatment of dry eye
- Systemic treatment of Meibomian Gland Dysfunction (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 product 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 with spermicide)
- 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.
About this study
The FOCUS study aims to evaluate the clinical efficacy of 0.1% cyclosporine eye drops solution (Vevizye®, Laboratoires THEA) in patients with moderate to severe dry eye disease characterized by ocular surface inflammation.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Cyclosporin
- 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.
CyclosporinDrug
This medicinal product contains cyclosporine 0.1% as an active ingredient and pefluorobutylpentane as vehicle.
What is being measured
The primary outcome is the main question the study is designed to answer.
Dryness score assessed by a VAS and Conjunctival hyperemia grading with Photographs (Efron) scale at week 12
Scores will be determined using a 100 mm VAS on which 0 means "no feeling of eye dryness" and 100 means "most imaginable feeling of eye dryness".
Measured: at week 12 versus baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start20 Jan 2026
- Primary completion1 Jun 2026
- Study completion1 Jun 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 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
- NCT07234318
- Sponsor's protocol ID
- LT10460-401
- Status last verified
- Aug 2026
- First submitted
- 14 Nov 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study
- ClinicalTrials.gov ID
- NCT07234318
- Acronym / sponsor ID
- LT10460-401
- Conditions
- Dry Eye Disease (DED)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 18 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.
The FOCUS study aims to evaluate the clinical efficacy of 0.1% cyclosporine eye drops solution (Vevizye®, Laboratoires THEA) in patients with moderate to severe dry eye disease characterized by ocular surface inflammation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recruited in University of Vienna
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- No patients with other ophthalmic diseases than DED
- Chronic dry eye defined as longer than six months since diagnosis
- OSDI score > 22
- Conjunctival Hyperemia ≥ Grade 3 (Efron Scale)
Key exclusion criteria (37 listed)
- Ophthalmic exclusion criteria
- Far best 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 |
|---|---|---|
| CyclosporinThis medicinal product contains cyclosporine 0.1% as an active ingredient and pefluorobutylpentane as vehicle. | Drug | – |
Primary outcome
Dryness score assessed by a VAS and Conjunctival hyperemia grading with Photographs (Efron) scale at week 12
Time frame: at week 12 versus baseline
Scores will be determined using a 100 mm VAS on which 0 means "no feeling of eye dryness" and 100 means "most imaginable feeling of eye dryness".
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 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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?
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 7 inclusion and 37 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 14 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 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?
Dryness score assessed by a VAS and Conjunctival hyperemia grading with Photographs (Efron) scale at week 12 (time frame: at week 12 versus baseline). 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 14 Aug 2026.