Corneal Ulcer, Keratitis
Conditions
Brief summary
The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.
Interventions
DEVICET4020
DEVICEVehicle
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients diagnosed with one chronic keratitis/corneal ulcer * Patients who signed and dated informed consent
Exclusion criteria
* Patient under 18 years * Patient with a perforated corneal ulcer OR any risk of immediate perforation of corneal ulcer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28 | Day 28 | Reduction in neurotrophic ulcer/keratitis area of 50% or more |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least One Treatment-emergent Adverse Event | From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days | With at least one TEAE |
| Best Corrected Visual Acuity | Baseline and Day 28 | Change from baseline in far best-corrected visual acuity (LogMAR) in the pathologic eye |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T4020 One drop every 2 days | 74 |
| Vehicle One drop every 2 days | 78 |
| Total | 152 |
Baseline characteristics
| Characteristic | Total | Vehicle | T4020 |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical >=65 years | 82 Participants | 45 Participants | 37 Participants |
| Age, Categorical Between 18 and 65 years | 69 Participants | 32 Participants | 37 Participants |
| Age, Continuous | 63.8 years STANDARD_DEVIATION 17.4 | 65.2 years STANDARD_DEVIATION 17.8 | 62.2 years STANDARD_DEVIATION 17 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Austria | 1 participants | 1 participants | 0 participants |
| Region of Enrollment Belgium | 14 participants | 8 participants | 6 participants |
| Region of Enrollment France | 36 participants | 20 participants | 16 participants |
| Region of Enrollment Greece | 12 participants | 6 participants | 6 participants |
| Region of Enrollment Italy | 13 participants | 6 participants | 7 participants |
| Region of Enrollment Netherlands | 8 participants | 4 participants | 4 participants |
| Region of Enrollment Poland | 26 participants | 14 participants | 12 participants |
| Region of Enrollment Portugal | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Spain | 12 participants | 5 participants | 7 participants |
| Region of Enrollment Sweden | 3 participants | 1 participants | 2 participants |
| Region of Enrollment Switzerland | 8 participants | 4 participants | 4 participants |
| Region of Enrollment Turkey | 15 participants | 7 participants | 8 participants |
| Region of Enrollment United Kingdom | 3 participants | 2 participants | 1 participants |
| Sex: Female, Male Female | 82 Participants | 42 Participants | 40 Participants |
| Sex: Female, Male Male | 70 Participants | 36 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 78 |
| other Total, other adverse events | 25 / 74 | 27 / 78 |
| serious Total, serious adverse events | 3 / 74 | 7 / 78 |
Outcome results
Primary
Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28
Reduction in neurotrophic ulcer/keratitis area of 50% or more
Time frame: Day 28
Population: Modified Intent to treat (m-ITT): All randomised patients received at least 1 IMP dose, with at least 1 baseline and 1 post-baseline efficacy assessment.~For the primary outcome measure, 4 patients (2 in the T4020 and Vehicle groups) had no data for the reduction from baseline of corneal ulcer/keratitis area and were not included in this analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T4020 | Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28 | 37 Participants |
| Vehicle | Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28 | 44 Participants |
Secondary
Best Corrected Visual Acuity
Change from baseline in far best-corrected visual acuity (LogMAR) in the pathologic eye
Time frame: Baseline and Day 28
Population: Safety set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T4020 | Best Corrected Visual Acuity | -0.055 LogMAR | Standard Deviation 0.362 |
| Vehicle | Best Corrected Visual Acuity | -0.035 LogMAR | Standard Deviation 0.59 |
Secondary
Number of Participants With at Least One Treatment-emergent Adverse Event
With at least one TEAE
Time frame: From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Population: Safety Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T4020 | Number of Participants With at Least One Treatment-emergent Adverse Event | 25 Participants |
| Vehicle | Number of Participants With at Least One Treatment-emergent Adverse Event | 27 Participants |