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

Not Applicable

Not yet recruiting

• Conditions: Moderate to Severe Vernal Keratoconjunctivitis
• Interventions: Diagnostic Test: Slit Lamp Examination; Diagnostic Test: Far Best Corrected Visual Acuity (BCVA); Drug: Ciclosporin; Drug: T1695; Diagnostic Test: Corneal fluorescein staining score on modified Oxford scale

• Registration Number: NCT07169695
• Lead Sponsor: Laboratoires Thea

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-05
• Study First Submitted QC: 2025-09-05
• Last Update Submitted: 2025-09-05
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Study Start: 2026-03-02
• Primary Completion: 2027-01-21
• Study Completion: 2027-01-21

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T1695	Slit Lamp Examination	The participant should instill T1695.
T1695	Far Best Corrected Visual Acuity (BCVA)	The participant should instill T1695.
T1695	Corneal fluorescein staining score on modified Oxford scale	The participant should instill T1695.
Ciclosporin	Slit Lamp Examination	The participant should instill Ciclosporin.
Ciclosporin	Far Best Corrected Visual Acuity (BCVA)	The participant should instill Ciclosporin.
Ciclosporin	Ciclosporin	The participant should instill Ciclosporin.
T1695	T1695	The participant should instill T1695.
Ciclosporin	Corneal fluorescein staining score on modified Oxford scale	The participant should instill Ciclosporin.

Primary Outcome Measures

Name	Time	Method
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