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

NCT ID: NCT07234318

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-06-30

Brief 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.

Conditions

Dry Eye Disease (DED)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Cyclosporin

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

Intervention Type: DRUG

Eligibility Criteria

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

• 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

•Known hypersensitivity to any of the components of the medical product under investigation or other study medication

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoires Thea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Medical Affairs Director

Role: CONTACT

Florence.NOIRT@theapharma.com

+33 4 73 98 14 36

Other Identifiers

LT10460-401

Identifier Type: -

Identifier Source: org_study_id