Trial Outcomes & Findings for Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome. (NCT NCT06375499)
NCT ID: NCT06375499
Last Updated: 2026-01-02
Results Overview
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)
COMPLETED
NA
74 participants
Oxford 0-15 grading scheme: is assessed at Day 1, Day 15 and Day 36
2026-01-02
Participant Flow
Participant milestones
| Measure |
T2769
T2769 (Thealoz® Total) T2769 is a sterile, phosphate-free and pH neutral solution. It contains Trehalose, Sodium Hyaluronate (SH) and Naaga.
|
Hylo-Forte
HYLO-FORTE® is a sterile, phosphate and preservative-free solution for ocular use containing sodium hyaluronate, citric acid anhydrous, sodium citrate and sorbitol.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
38
|
|
Overall Study
COMPLETED
|
35
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
T2769
n=36 Participants
Test device: T2769 (Thealoz® Total) T2769 is a sterile, phosphate-free and pH neutral solution. It contains Trehalose, Sodium Hyaluronate (SH) and Naaga.
|
Hylo-Forte
n=38 Participants
HYLO-FORTE® is a sterile, phosphate and preservative-free solution for ocular use containing sodium hyaluronate, citric acid anhydrous, sodium citrate and sorbitol.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 14.42 • n=36 Participants
|
47.5 years
STANDARD_DEVIATION 14.44 • n=38 Participants
|
50.6 years
STANDARD_DEVIATION 14.68 • n=74 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=36 Participants
|
30 Participants
n=38 Participants
|
57 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=36 Participants
|
8 Participants
n=38 Participants
|
17 Participants
n=74 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Hungary
|
30 participants
n=36 Participants
|
35 participants
n=38 Participants
|
65 participants
n=74 Participants
|
|
Region of Enrollment
Czechia
|
6 participants
n=36 Participants
|
3 participants
n=38 Participants
|
9 participants
n=74 Participants
|
PRIMARY outcome
Timeframe: Oxford 0-15 grading scheme: is assessed at Day 1, Day 15 and Day 36Population: Day 1-Baseline
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)
Outcome measures
| Measure |
T2769
n=35 Participants
Test device: T2769 (Thealoz® Total)
|
Hylo-Forte
n=38 Participants
Comparator: HYLO-FORTE®
|
|---|---|---|
|
To Demonstrate the Non-inferiority of T2769 Compared to Hylo-Forte® in Terms of Total Ocular Surface Staining (Oxford Score).
|
-1.3 score on a scale
Interval -2.0 to -0.5
|
-1.2 score on a scale
Interval -1.9 to -0.5
|
Adverse Events
Hylo-Forte
T2769
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place