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NCT07234318

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

Sponsor: Laboratoires Thea

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

Start Date

2025-12-15

Completion Date

2026-06-30

Last Updated

2025-11-18

Healthy Volunteers

Conditions

Dry Eye Disease (DED)

Interventions

DRUG

Cyclosporin

This medicinal product contains cyclosporine 0.1% as an active ingredient and pefluorobutylpentane as vehicle.

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 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) Exclusion criteria related to general conditions * 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