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

The objective is to demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of the change from baseline (D1) in total ocular surface staining score assessed on Oxford 0-15 scale, in the study eye at the D36 visit.

The investigation is defined as a post-market stage. The clinical investigation design is confirmatory.

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Axon Clinical, s.r.o., Prague, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria (At Screening visit):

Informed consent signed and dated (obtained prior to initiating any procedures).
Patient aged ≥18 years old.
Persistence of dry eye syndrome, despite artificial tears use in the previous month prior to the screening visit

Main Exclusion Criteria (At both Screening and Randomisation visits):

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

Treatment and study plan

T2769

Device

Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily.

Hylo-Forte®

Device

Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily.

Primary outcomes

To Demonstrate the Non-inferiority of T2769 Compared to Hylo-Forte® in Terms of Total Ocular Surface Staining (Oxford Score).

Time frame: Oxford 0-15 grading scheme: is assessed at Day 1, Day 15 and Day 36

The primary endpoint is the change from baseline (Day 1) in total ocular surface staining grade according to Oxford Scale 0-15 grading scheme at D36 in the study eye. Minimum value is 0 (better case) and maximum value is 15 (worse case)

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Apr 19, 2024
Registry last updated: Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed