Trial Outcomes & Findings for Efficacy, Safety of T2769 in Dry Eye Disease (NCT NCT03830359)
NCT ID: NCT03830359
Last Updated: 2022-03-16
Results Overview
Change from baseline in ocular symptomatology on a Visual Analog Scale (0=No discomfort and 100=Maximal discomfort) at Day 42.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
Baseline and Day 42
Results posted on
2022-03-16
Participant Flow
Participant milestones
| Measure |
T2769
T2769 : 1 drop in each eye 3 to 6 times daily during 42 days
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
62
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy, Safety of T2769 in Dry Eye Disease
Baseline characteristics by cohort
| Measure |
T2769
n=62 Participants
T2769 Ophthalmic solution One drop in each eye 3 to 6 times daily
T2769: 62 patients treated by T2769 for 42 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
62 Participants
n=5 Participants
|
|
Region of Enrollment
Tunisia
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 42Population: m-ITT population : all enrolled patients having received at least one dose of the IP and with at least one baseline and post-baseline efficacy assessment.
Change from baseline in ocular symptomatology on a Visual Analog Scale (0=No discomfort and 100=Maximal discomfort) at Day 42.
Outcome measures
| Measure |
T2769
n=62 Participants
T2769 Ophthalmic solution One drop in each eye 3 to 6 times daily
T2769: 62 patients treated by T2769 for 42 days
|
|---|---|
|
Ocular Symptomatology
|
-55.9 units on a scale
Standard Deviation 23.1
|
Adverse Events
T2769
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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