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

NCT07234318 | Not Yet Recruiting

• 1 other identifier: LT10460-401
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Cyclosporin DRUG

This medicinal product contains cyclosporine 0.1% as an active ingredient and pefluorobutylpentane as vehicle.

Eligibility Criteria

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

Study Population

Patients recruited in University of Vienna

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 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

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

• Laboratoires Thea: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Medical Affairs Director

CONTACT

+33 4 73 98 14 36; Florence.NOIRT@theapharma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: December 15, 2025
• Primary Completion: March 15, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11