A Study to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants With Moderate to Severe Vernal Keratoconjunctivitis

ConditionModerate to Severe Vernal Keratoconjunctivitis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age4-17

SponsorLaboratoires Thea

About this trial

The aim of the study is to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants with Moderate to Severe Vernal Keratoconjunctivitis

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Slit Lamp Examination
Diagnostic test
The participant will have a slit lamp examination
Far Best Corrected Visual Acuity (BCVA)
Diagnostic test
The participant 's BCVA will be evaluated.
T1695
Drug
The participant should instill T1695.
Ciclosporin
Drug
The participant should instill Ciclosporin.
Corneal fluorescein staining score on modified Oxford scale
Diagnostic test
One drop of fluorescein will be instilled to assess the fluorescein staining score on the modified Oxford scale.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: T1695Experimental treatment 4 interventions

Group B: CiclosporinActive comparator 4 interventions

Trial outcomes

Primary outcomes

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.

Time frame

From Day 1 to Day 29

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laboratoires Thea

Lead sponsor

Source ClinicalTrials.gov

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