RECRUITINGPhase 4INTERVENTIONAL

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

About This Trial

Dry eye disease (DED) is a common, multifactorial ocular surface condition with increasing worldwide prevalence. DED induces a significant burden to the patients. Inflammatory responses involving the ocular surface including the adnexa, conjunctiva and cornea are recognized as central to its pathophysiology, as supported by in vitro, non-clinical and clinical studies. Although tear substitutes remain the mainstay of initial management, in some patients this is not sufficient to control ocular surface inflammation and associated symptoms. A new medical product (Vevizye® eye drops) has been recently approved for the treatment of DED. It contains cyclosporine 0.1% as an active ingredient and pefluorobutylpentane as vehicle. Topical cyclosporine is a well-established treatment for patients with moderate to severe DED who do not achieve sufficient clinical benefit from topical lubricants alone. Perfluorobutylpentane has been found to improve the bioavailability of cyclosporine and has a long residence time for up to 8 hours. In addition, because of its low surface tension facilitates quick and uniform spreading improving the tear film layer. 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 DED characterized by ocular surface inflammation.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - Need to add cyclosporine eye drops to tear substitutes as judged by treating physician prior to and independently of study participation Who Should NOT Join This Trial: 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 - Uveitis - Ocular surgery Exclusion criteria related to general conditions: - Inability of patient to understand the investigation procedures and thus inability to give valid, willing to sign a consent form. - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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 * Need to add cyclosporine eye drops to tear substitutes as judged by treating physician prior to and independently of study participation 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 * Uveitis * Ocular surgery 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

Treatments Being Tested

DRUG

Vevizye® Eye Drops

Vevizye® Eye Drops, Laboratoires Thea, Clermont Ferrand, France Administration scheme: 2 times daily for 12 weeks with a 12h time interval Ingredients: Cyclosporine 1mg/mL, Perfluorobutylpentane, Ethanol, anhydrous

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna, Austria

Vienna, Vienna, Austria