Dry Eye Syndromes
Conditions
Brief summary
The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.
Interventions
DEVICET2259
Sodium Hyaluronate and Trehalose
DEVICEVismed multi
HA
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
investigator-masked
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main 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 Main
Exclusion criteria
* Far best-corrected visual acuity≤2/10 * Severe Blepharitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15) | Baseline and Day 35 | Change from baseline in the worse eye at Day 35 in Global Ocular staining (decrease of oxford score = better outcome) |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T2259 1 drop in each eye 2 to 4 times daily
T2259 | 49 |
| Vismed Multi 1 drop in each eye 2 to 4 times daily
Vismed multi | 49 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Covid-19 pandemic | 4 | 2 |
| Overall Study | Lack of Efficacy | 0 | 1 |
Baseline characteristics
| Characteristic | T2259 | Vismed Multi | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 8 Participants | 33 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 41 Participants | 65 Participants |
| Age, Continuous age | 62.4 years STANDARD_DEVIATION 13.7 | 55.5 years STANDARD_DEVIATION 13.1 | 59 years STANDARD_DEVIATION 13.8 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment France | 11 participants | 8 participants | 19 participants |
| Region of Enrollment Poland | 4 participants | 6 participants | 10 participants |
| Region of Enrollment Slovakia | 22 participants | 25 participants | 47 participants |
| Region of Enrollment Spain | 12 participants | 10 participants | 22 participants |
| Sex: Female, Male Female | 43 Participants | 44 Participants | 87 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 51 |
| other Total, other adverse events | 4 / 50 | 0 / 51 |
| serious Total, serious adverse events | 0 / 50 | 1 / 51 |
Outcome results
Primary
Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15)
Change from baseline in the worse eye at Day 35 in Global Ocular staining (decrease of oxford score = better outcome)
Time frame: Baseline and Day 35
Population: PP population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T2259 | Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15) | -1.45 score on a scale | Standard Deviation 1.88 |
| Vismed Multi | Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15) | -1.79 score on a scale | Standard Deviation 1.68 |
Comparison: To assess the non inferiority of T2259 compared to Vismed Multi, two-sided 95% confidence interval from ANCOVA model was computed of the difference of T2259 minus Vismed Multi. The model was adjusted for the main effects of investigation product and baseline score.95% CI: [-0.42, 1.05]ANCOVA