A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of… (NCT07234318) | Clinical Trial Compass
CompletedNot Applicable
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
Austria25 participantsStarted 2026-01-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
Ophthalmic exclusion criteria
* Far best corrected visual acuity \< 1/10
* Severe Dry Eye associated with:
* Eyelid malposition
* Stevens Johnson Syndrome
* Corneal dystrophy
* 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 exclusio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is looking at a water-free cyclosporin 0.1% eye drop specifically for people whose dry eye hasn't responded to artificial tears — does my current level of response to artificial tears actually match what this study is looking for?
2Since this is a non-interventional study, can you explain what that means for my care — will I be receiving a treatment that's already part of standard practice, or is there something different about how I'd be monitored compared to normal treatment?
3The study is no longer recruiting new patients — does that mean there's any chance I could still participate, or should we be focusing entirely on other treatment options for my dry eye right now?
4The trial measures dryness and eye redness at 12 weeks using specific grading tools — how do those outcomes compare to what you'd use to judge whether a treatment is working for me in regular care?
5Given that cyclosporin eye drops are already used for dry eye disease, are there currently approved or available versions of this medication we could discuss as an alternative while this study completes?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dryness score assessed by a VAS and Conjunctival hyperemia grading with Photographs (Efron) scale at week 12