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)

May 4, 2026 updated by: Doreen Schmidl, Medical University of Vienna
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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Week 0 - 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes from baseline in conjunctival hyperemia grading with photographs (Efron) scale
Time Frame: At weeks 2, 4, 8 & 12:

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)
Time Frame: At weeks 2, 4, 8 & 12:

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
Time Frame: At weeks 2, 4, 8 & 12:

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%
Time Frame: At weeks 2, 4, 8 & 12:

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
Time Frame: At weeks 2, 4, 8 & 12:

Changes from baseline in lipid layer thickness

unit: nanometers
At weeks 2, 4, 8 & 12:
Changes from baseline in tear film osmolarity
Time Frame: At weeks 2, 4, 8 & 12:

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
Time Frame: At weeks 2, 4, 8 & 12:

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
Time Frame: At weeks 2, 4, 8 & 12
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
Time Frame: At weeks 2, 4, 8 & 12:
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
Time Frame: At weeks 2, 4, 8 & 12
Changes from baseline in symptoms within the last 48 hours
At weeks 2, 4, 8 & 12
Patient satisfaction assessed by a VAS
Time Frame: At week 12

Patient satisfaction assessed by a VAS

Scale 0-100; min 0; max 100 Unit: millimeter
At week 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Week 0 - 12
Adverse events
Week 0 - 12
Best corrected distance visual acuity
Time Frame: 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)
Time Frame: Week 2 - 12
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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