Keratoconus
Conditions
Brief summary
The purpose of this study is to assess the performance and safety of T4020 versus saline solution.
Interventions
DEVICET4020
DEVICEPlacebo
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients diagnosed with progressive keratoconus * Patients who signed and dated informed consent
Exclusion criteria
* Patient under 18 years * History within 1 month or any active ocular infection, ocular injury, and associated corneal ulceration and abscess * Corneal thickness\< 400µm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3 | Day 3 |
| Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4 | Day 4 |
Secondary
| Measure | Time frame |
|---|---|
| Corneal Epithelial Defect Size Assessment | Baseline and Day 5 |
| Number of Participants With Treatment-emergent Adverse Events | Through study completion, an average of 1 month |
Countries
Bulgaria, France, Spain, Turkey (Türkiye)
Participant flow
Pre-assignment details
157 screened patients disposed as: 135 patients treated and randomised, 20 patients not included (reasons: screen failures: 14, protocol violation: 1, consent withdrawal: 4 and other reasons: 1) and 2 patients treated but not randomised.
Participants by arm
| Arm | Count |
|---|---|
| T4020 1 drop every other day during 5 days
T4020 | 71 |
| Saline Solution 1 drop every other day during 5 days
Placebo | 64 |
| Total | 135 |
Baseline characteristics
| Characteristic | T4020 | Saline Solution | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants | 59 Participants | 127 Participants |
| Age, Continuous | 27.5 years STANDARD_DEVIATION 7.9 | 28.9 years STANDARD_DEVIATION 10.2 | 28.1 years STANDARD_DEVIATION 9.1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Bulgaria | 15 participants | 14 participants | 29 participants |
| Region of Enrollment France | 21 participants | 17 participants | 38 participants |
| Region of Enrollment Spain | 16 participants | 15 participants | 31 participants |
| Region of Enrollment Turkey | 19 participants | 18 participants | 37 participants |
| Sex: Female, Male Female | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Male | 50 Participants | 44 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 73 | 0 / 64 |
| other Total, other adverse events | 12 / 73 | 8 / 64 |
| serious Total, serious adverse events | 0 / 73 | 0 / 64 |
Outcome results
Primary
Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3
Time frame: Day 3
Population: mITT set (135 participants) analysed results. 137 treated participants: 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T4020 | Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3 | 20 Participants |
| Saline Solution | Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3 | 25 Participants |
Primary
Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4
Time frame: Day 4
Population: mITT set (135 participants) analysed results. 137 treated participants: 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T4020 | Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4 | 47 Participants |
| Saline Solution | Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4 | 47 Participants |
Secondary
Corneal Epithelial Defect Size Assessment
Time frame: Baseline and Day 5
Population: mITT set (135 participants) analysed results. 137 treated participants: 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T4020 | Corneal Epithelial Defect Size Assessment | 1.0 mm^2 | Standard Deviation 4.6 |
| Saline Solution | Corneal Epithelial Defect Size Assessment | 1.9 mm^2 | Standard Deviation 6.9 |
Secondary
Number of Participants With Treatment-emergent Adverse Events
Time frame: Through study completion, an average of 1 month
Population: Safety set (137 treated participants)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T4020 | Number of Participants With Treatment-emergent Adverse Events | 12 Participants |
| Saline Solution | Number of Participants With Treatment-emergent Adverse Events | 8 Participants |