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

Comparison of the 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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Device: T2769; Device: Hylo-Forte®

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 11800
    • OFTEX, s.r.o.
  • Prague, Czechia, 15000
    • Axon Clinical, s.r.o.
• Hungary
  • Baranya
    • Pécs, Baranya, Hungary, 7621
      • Ganglion Medical Center
  • Hb
    • Létavértes, Hb, Hungary, 4281
      • Ermellek Egeszsegcentrum

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T2769; Hyaluronic acid, Trehalose, Naaga Route of administration: topical, ocular use	Device: T2769; Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily.
Active Comparator: Hylo-Forte®; Hyaluronic acid Route of administration: topical, ocular use	Device: Hylo-Forte®; Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Demonstrate the Non-inferiority of T2769 Compared to Hylo-Forte® in Terms of Total Ocular Surface Staining (Oxford Score).	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)	Oxford 0-15 grading scheme: is assessed at Day 1, Day 15 and Day 36

Collaborators and Investigators

• Sponsor: Laboratoires Thea

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Actual): January 6, 2025
• Study Completion (Actual): January 6, 2025

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: LT2769-004

Drug and device information, study documents

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