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

Phase 2RecruitingNCT07169695

Laboratoires Thea120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Moderate to Severe Vernal Keratoconjunctivitis

Interventions

Slit Lamp ExaminationDIAGNOSTIC_TEST

The participant will have a slit lamp examination

Far Best Corrected Visual Acuity (BCVA)DIAGNOSTIC_TEST

The participant 's BCVA will be evaluated.

T1695DRUG

The participant should instill T1695.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (11)

Disha Eye Hospitals - Barrackpore

Kolkata, West Bengal, India

RECRUITING

M&J Institute of Ophthalmology

Ahmedabad, India

NOT_YET_RECRUITING

Netralaya Super Speciality Eye Hospital

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

Central Contacts

Corentin LE CAMUS

CONTACT

+33473981436 Corentin.LECAMUS@theapharma.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.