Moderate to Severe Vernal Keratoconjunctivitis
Conditions
Keywords
Vernal Keratoconjunctivitis
Brief summary
The aim of the study is to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants with Moderate to Severe Vernal Keratoconjunctivitis
Interventions
DIAGNOSTIC_TESTSlit Lamp Examination
The participant will have a slit lamp examination
DIAGNOSTIC_TESTFar Best Corrected Visual Acuity (BCVA)
The participant 's BCVA will be evaluated.
DRUGT1695
The participant should instill T1695.
DRUGCiclosporin
The participant should instill Ciclosporin.
DIAGNOSTIC_TESTCorneal fluorescein staining score on modified Oxford scale
One drop of fluorescein will be instilled to assess the fluorescein staining score on the modified Oxford scale.
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Informed consent signed and dated * Male or female participant from 4 years to less than 18 years old. * Participant with grading score of 3 or 4 on the Bonini scale for clinical grading of VKC in each eye. Main
Exclusion criteria
Participants must not have any conditions which might exclude them from participating, could interfere with the study, or pose an unacceptable risk to their health.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline (Day 1) at Day 29 (Week 4) in Corneal Fluorescein Staining (CFS) grade assessed by the (0-5) modified Oxford scale in the study eye. | From Day 1 to Day 29 |
Contacts
Primary ContactCorentin LE CAMUS
Outcome results
None listed