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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dry Eye Disease (DED)
• Intervention / Treatment: Drug: Cyclosporin

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients recruited in University of Vienna

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 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dryness score assessed by a VAS and Conjunctival hyperemia grading with Photographs (Efron) scale at week 12	Scores will be determined using a 100 mm VAS on which 0 means "no feeling of eye dryness" and 100 means "most imaginable feeling of eye dryness".	at week 12 versus baseline

Collaborators and Investigators

• Sponsor: Laboratoires Thea

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Estimated): June 9, 2026
• Study Completion (Estimated): June 9, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 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; Peptides; Amino Acids, Peptides, and Proteins; Polycyclic Compounds; Macrocyclic Compounds; Peptides, Cyclic; Cyclosporins; Cyclosporine
• Other Study ID Numbers: LT10460-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No