Dry Eye Syndrome
Conditions
Brief summary
Efficacy of T2769 in Dry Eye Desease
Detailed description
Multicenter and open study
Interventions
OTHERT2769
At least 55 enrolled patients for at least 50 evaluable patients treated by T2769 for 42 days
Sponsors
Laboratoires Thea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed and dated informed consent * Male or female aged from ≥ 18 years old * Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study screening
Exclusion criteria
* Best far corrected visual acuity ≤ 2/10 * Severe blepharitis Severe dry eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Symptomatology | Baseline and Day 42 | Change from baseline in ocular symptomatology on a Visual Analog Scale (0=No discomfort and 100=Maximal discomfort) at Day 42. |
Countries
Tunisia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T2769 T2769 Ophthalmic solution One drop in each eye 3 to 6 times daily
T2769: 62 patients treated by T2769 for 42 days | 62 |
| Total | 62 |
Baseline characteristics
| Characteristic | T2769 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants |
| Age, Continuous | 52.4 years STANDARD_DEVIATION 11.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 62 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Tunisia | 62 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 62 |
| other Total, other adverse events | 0 / 62 |
| serious Total, serious adverse events | 0 / 62 |
Outcome results
Primary
Ocular Symptomatology
Change from baseline in ocular symptomatology on a Visual Analog Scale (0=No discomfort and 100=Maximal discomfort) at Day 42.
Time frame: Baseline and Day 42
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T2769 | Ocular Symptomatology | -55.9 units on a scale | Standard Deviation 23.1 |