Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of T… (NCT07234318) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
25 participantsStarted 2025-12-15
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 range18 Years
SexALL
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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…
What they're measuring
1
Dryness score assessed by a VAS and Conjunctival hyperemia grading with Photographs (Efron) scale at week 12