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

NCT06375499 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-01-02

Study results available
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Summary

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.

Conditions

  • Dry Eye Syndrome

Interventions

DEVICE

T2769

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

DEVICE

Hylo-Forte®

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

Sponsors & Collaborators

  • Laboratoires Thea

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-17
Primary Completion
2025-01-06
Completion
2025-01-06

Countries

  • Czechia
  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06375499 on ClinicalTrials.gov