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

NCT07463950 | Terminated Phase 4

• 1 other identifier: LT10460-401
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Changes from baseline in conjunctival hyperemia grading with photographs (Efron) scale

  At weeks 2, 4, 8 & 12:

• Change from baseline in dryness score (VAS)

  At weeks 2, 4, 8 & 12:

• Changes from baseline in corneal fluorescein staining according to the NEI Scale

  At weeks 2, 4, 8 & 12:

• Changes from baseline in Tear Break Up Time (BUT) with Minims- Fluorescein Sodium 2,0%

  At weeks 2, 4, 8 & 12:

• Changes from baseline in lipid layer thickness

  At weeks 2, 4, 8 & 12:

Other Outcomes (3)

• Adverse events

  Week 0 - 12

• 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)

  Week 2 - 12

Study Arms (1)

Vevizye® Eye Drops

EXPERIMENTAL

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

Interventions

Vevizye® Eye Drops DRUG

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

Vevizye® Eye Drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna, Austria

Vienna, State of Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv. Doz. Dr., PhD

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: March 11, 2026
• Study Start: January 20, 2026
• Primary Completion: May 4, 2026
• Study Completion: May 4, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

AU (1)