Completed

Comparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome.

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What is being tested

T2769

+ Hylo-Forte®

Device
Who is being recruted

Eye Diseases

+ Lacrimal Apparatus Diseases

+ Dry Eye Syndromes

Over 18 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2024
See protocol details

Summary

Principal SponsorLaboratoires Thea
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 17, 2024

Actual date on which the first participant was enrolled.

This study aims to evaluate whether a new eye treatment, called T2769, is as effective and safe as an existing treatment, Hylo-Forte®, for people suffering from moderate to severe dry eye syndrome. Dry eye syndrome is a common condition that can cause discomfort and vision problems. The study is important because finding a treatment that is as good as or better than current options could improve quality of life for many individuals experiencing this condition. Participants in the study will be using either T2769 or Hylo-Forte® to treat their eyes, and the effectiveness will be measured by looking at changes in the eye’s surface using a specific scale. This scale, known as the Oxford 0-15 scale, helps to assess how much the eye has improved over time. The study will compare the results from the beginning of the trial to the results observed on day 36. Since this is a late-stage study, it focuses on confirming the safety and performance of the T2769 treatment in a real-world setting.

Official TitleComparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome.
NCT06375499
Principal SponsorLaboratoires Thea
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

74 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesLacrimal Apparatus DiseasesDry Eye Syndromes

Criteria

2 exclusion criteria prevent from participating
Far Best-Corrected Visual Acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 letters Early Treatment Diabetic Retinopathy Study (ETDRS)).

Patient with previous or current ophthalmic condition

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Hyaluronic acid, Trehalose, Naaga Route of administration: topical, ocular use

Group II

Active Comparator
Hyaluronic acid Route of administration: topical, ocular use

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

OFTEX, s.r.o.

Prague, CzechiaOpen OFTEX, s.r.o. in Google Maps
Suspended

Axon Clinical, s.r.o.

Prague, Czechia
Suspended

Ganglion Medical Center

Pécs, Hungary
Suspended

Ermellek Egeszsegcentrum

Létavértes, Hungary
Completed4 Study Centers