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 (LT10460-401)

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.

Study Overview

• Status: Terminated
• Conditions: Dry Eye Disease (DED)
• Intervention / Treatment: Drug: Vevizye® Eye Drops

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • State of Vienna
    • Vienna, State of Vienna, Austria, 1090
      • Department of Clinical Pharmacology, Medical University of Vienna, Austria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dryness score assessed by a Visual Analog Scale (VAS) and Conjunctival hyperemia grading with Photographs (Efron) scale at week 12	Dryness score assessed by a VAS score 0-100; min 0; max 100 Unit: millimeters and Conjunctival hyperemia grading with Photographs (Efron) scale at week 12 score: 0-4; min 0, max 4	Week 0 - Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in conjunctival hyperemia grading with photographs (Efron) scale	Changes from baseline in conjunctival hyperemia grading with photographs (Efron) scale Scale 0-4; min 0; max 4	At weeks 2, 4, 8 & 12:
Change from baseline in dryness score (VAS)	Change from baseline in dryness score (VAS) Scale 0-100; min 0; max 100 unit: millimeter	At weeks 2, 4, 8 & 12:
Changes from baseline in corneal fluorescein staining according to the NEI Scale	Changes from baseline in corneal fluorescein staining according to the NEI Scale Scale 0-15; min 0; max 15	At weeks 2, 4, 8 & 12:
Changes from baseline in Tear Break Up Time (BUT) with Minims- Fluorescein Sodium 2,0%	Changes from baseline in Tear Break Up Time (BUT) with Minims- Fluorescein Sodium 2,0% Unit: seconds	At weeks 2, 4, 8 & 12:
Changes from baseline in lipid layer thickness	Changes from baseline in lipid layer thickness unit: nanometers	At weeks 2, 4, 8 & 12:
Changes from baseline in tear film osmolarity	Changes from baseline in tear film osmolarity Scale <275 - >400; min <275; max >400 Unit: mOsms/L	At weeks 2, 4, 8 & 12:
Changes from baseline in Schirmer I test using Schirmer paper strips	Changes from baseline in Schirmer I test using Schirmer paper strips Scale 0-40; min 0; max 40 Unit: millimeter	At weeks 2, 4, 8 & 12:
Changes from baseline in conjunctival hyperemia assessment using Mc Monnies photographic scale	Changes from baseline in conjunctival hyperemia assessment using Mc Monnies photographic scale	At weeks 2, 4, 8 & 12
Changes from baseline in symptoms and quality of life using the OSDI questionnaire	Changes from baseline in symptoms and quality of life using the OSDI questionnaire	At weeks 2, 4, 8 & 12:
Changes from baseline in symptoms within the last 48 hours	Changes from baseline in symptoms within the last 48 hours	At weeks 2, 4, 8 & 12
Patient satisfaction assessed by a VAS	Patient satisfaction assessed by a VAS Scale 0-100; min 0; max 100 Unit: millimeter	At week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events	Week 0 - 12
Best corrected distance visual acuity	Best corrected distance visual acuity	Week 0 - 12
Questionnaire of tolerability at instillation, 15 minutes and 12 hours afterwards (pain, burning, blurred vision, foreign body sensation, itching)	Questionnaire of tolerability at instillation, 15 minutes and 12 hours afterwards (pain, burning, blurred vision, foreign body sensation, itching)	Week 2 - 12

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Actual): May 4, 2026
• Study Completion (Actual): May 4, 2026

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: LT10460-401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No