Dry Eye Syndrome
Conditions
Brief summary
Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome
Interventions
DEVICET2762
1 drop in each eye 3 to 6 times daily during 84 days
DEVICEVismed®
1 drop in each eye 3 to 6 times daily during 84 days
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
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 selection.
Exclusion criteria
* Best far corrected visual acuity \< 1/10 * Severe blepharitis * Severe Dry Eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Ocular Staining (With Oxford Scale - Ranges : 0-15) | Baseline and Day 35 | Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome) Global Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed). |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T2762 T2762: 1 drop in each eye 3 to 6 times daily during 84 days | 52 |
| Vismed® Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days | 53 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | T2762 | Vismed® | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 18 Participants | 36 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 35 Participants | 69 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 12.2 | 58.5 years STANDARD_DEVIATION 13.4 | 59.2 years STANDARD_DEVIATION 12.8 |
| Region of Enrollment France | 31 participants | 31 participants | 62 participants |
| Region of Enrollment Tunisia | 21 participants | 22 participants | 43 participants |
| Sex: Female, Male Female | 41 Participants | 45 Participants | 86 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 53 |
| serious Total, serious adverse events | 0 / 52 | 0 / 53 |
Outcome results
Primary
Global Ocular Staining (With Oxford Scale - Ranges : 0-15)
Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome) Global Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed).
Time frame: Baseline and Day 35
Population: 14 patients with major protocol deviations were excluded of the analysed population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T2762 | Global Ocular Staining (With Oxford Scale - Ranges : 0-15) | -2.5 score on a scale | Standard Deviation 2 |
| Vismed | Global Ocular Staining (With Oxford Scale - Ranges : 0-15) | -2.7 score on a scale | Standard Deviation 1.7 |