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

Thea Pharma

Status: Not yet enrolling

Conditions: Dry Eye Disease (DED)

Treatments: Drug: Cyclosporin

Study type: Observational

Funder types: Industry

Identifiers

NCT07234318

LT10460-401

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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