Trial Outcomes & Findings for Performance and Safety of T2769 in DED (NCT NCT05965778)
NCT ID: NCT05965778
Last Updated: 2026-01-23
Results Overview
Change from baseline (Day 1) in the worse eye at Day 36 in Global Ocular staining (decrease of oxford score = better outcome)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
251 participants
Primary outcome timeframe
Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36
Results posted on
2026-01-23
Participant Flow
Participant milestones
| Measure |
T2769
1 drop in each eye, 3 to 6 times daily
T2769: T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.
|
Vismed® Multi
1 drop in each eye, 3 to 6 times daily
Vismed® Multi: Hyaluronic acid
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
126
|
|
Overall Study
COMPLETED
|
113
|
111
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
Reasons for withdrawal
| Measure |
T2769
1 drop in each eye, 3 to 6 times daily
T2769: T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.
|
Vismed® Multi
1 drop in each eye, 3 to 6 times daily
Vismed® Multi: Hyaluronic acid
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
divers reasons(patient or doctor not available for visit...),
|
9
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total
n=251 Participants
Total of all reporting groups
|
T2769
n=125 Participants
1 drop in each eye, 3 to 6 times daily
T2769: Sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.
|
Vismed® Multi
n=126 Participants
1 drop in each eye, 3 to 6 times daily
Vismed® Multi: Hyaluronic acid
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=251 Participants
|
0 Participants
n=125 Participants
|
0 Participants
n=126 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
150 Participants
n=251 Participants
|
74 Participants
n=125 Participants
|
76 Participants
n=126 Participants
|
|
Age, Categorical
>=65 years
|
101 Participants
n=251 Participants
|
51 Participants
n=125 Participants
|
50 Participants
n=126 Participants
|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 14.34 • n=251 Participants
|
58.7 years
STANDARD_DEVIATION 15.04 • n=125 Participants
|
60.1 years
STANDARD_DEVIATION 13.64 • n=126 Participants
|
|
Sex: Female, Male
Female
|
204 Participants
n=251 Participants
|
100 Participants
n=125 Participants
|
104 Participants
n=126 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=251 Participants
|
25 Participants
n=125 Participants
|
22 Participants
n=126 Participants
|
|
Race and Ethnicity Not Collected
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
—
|
—
|
|
Region of Enrollment
France
|
3 Participants
n=251 Participants
|
3 Participants
n=125 Participants
|
0 Participants
n=126 Participants
|
|
Region of Enrollment
Austria
|
30 Participants
n=251 Participants
|
15 Participants
n=125 Participants
|
15 Participants
n=126 Participants
|
|
Region of Enrollment
Spain
|
89 Participants
n=251 Participants
|
43 Participants
n=125 Participants
|
46 Participants
n=126 Participants
|
|
Region of Enrollment
Greece
|
27 Participants
n=251 Participants
|
14 Participants
n=125 Participants
|
13 Participants
n=126 Participants
|
|
Region of Enrollment
Hungary
|
11 Participants
n=251 Participants
|
6 Participants
n=125 Participants
|
5 Participants
n=126 Participants
|
|
Region of Enrollment
Israel
|
32 Participants
n=251 Participants
|
16 Participants
n=125 Participants
|
16 Participants
n=126 Participants
|
|
Region of Enrollment
Italy
|
28 Participants
n=251 Participants
|
11 Participants
n=125 Participants
|
17 Participants
n=126 Participants
|
|
Region of Enrollment
Slovakia
|
31 Participants
n=251 Participants
|
17 Participants
n=125 Participants
|
14 Participants
n=126 Participants
|
PRIMARY outcome
Timeframe: Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36Change from baseline (Day 1) in the worse eye at Day 36 in Global Ocular staining (decrease of oxford score = better outcome)
Outcome measures
| Measure |
T2769
n=123 Participants
1 drop in each eye, 3 to 6 times daily
T2769: T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.
|
Vismed® Multi
n=121 Participants
1 drop in each eye, 3 to 6 times daily
Vismed® Multi: Hyaluronic acid
|
|---|---|---|
|
Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : Minimum 0- Maximum 15)
|
-2.3 score on a scale
Standard Deviation 1.99
|
-2.1 score on a scale
Standard Deviation 2.08
|
Adverse Events
T2769
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vismed® Multi
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
T2769
n=125 participants at risk
1 drop in each eye, 3 to 6 times daily
T2769: T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.
|
Vismed® Multi
n=126 participants at risk
1 drop in each eye, 3 to 6 times daily
Vismed® Multi: Hyaluronic acid
|
|---|---|---|
|
Injury, poisoning and procedural complications
Limb fracture
|
0.00%
0/125 • 7 weeks from D-10 to D36 (+3 days)
|
0.79%
1/126 • Number of events 1 • 7 weeks from D-10 to D36 (+3 days)
|
|
Renal and urinary disorders
haematuria
|
0.00%
0/125 • 7 weeks from D-10 to D36 (+3 days)
|
0.79%
1/126 • Number of events 1 • 7 weeks from D-10 to D36 (+3 days)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER