At a glance
ClinicalIndex Comparison RecordN/ACompleted· 74 enrolled
Drug / intervention
T2769 +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome.
In Brief
A clinical study evaluating T2769 and Hylo-Forte® for Dry Eye Syndrome. Completed, enrolled 74 participants across 4 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndrome
CountriesCzechia, Hungary
Collaborators--
Timeline
N/ACompletedFinished
20252026
First PostedApr 2024
Enrollment StartSep 2024
Primary CompletionJan 2025
TodayJul 2026
First PostedApr 19, 2024
Enrollment StartSep 17, 2024
Primary CompletionJan 6, 2025
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 2.2 years ago
Interventions
T2769device
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.