Trials / Completed
CompletedNCT06375499
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- Laboratoires Thea · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-09-17
- Primary completion
- 2025-01-06
- Completion
- 2025-01-06
- First posted
- 2024-04-19
- Last updated
- 2026-01-02
- Results posted
- 2026-01-02
Locations
4 sites across 2 countries: Czechia, Hungary
Source: ClinicalTrials.gov record NCT06375499. Inclusion in this directory is not an endorsement.