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

Thea Pharma

Status and phase: Begins enrollment this month; Phase 2

Conditions: Moderate to Severe Vernal Keratoconjunctivitis

Treatments: Diagnostic Test: Corneal fluorescein staining score on modified Oxford scale; Drug: T1695; Diagnostic Test: Far Best Corrected Visual Acuity (BCVA); Diagnostic Test: Slit Lamp Examination; Drug: Ciclosporin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07169695

2025-521567-12-00 (EU Trial (CTIS) Number)

LT1695-201

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

T1695

Experimental group

Description:

The participant should instill T1695.

Treatment:

Diagnostic Test: Slit Lamp Examination

Diagnostic Test: Far Best Corrected Visual Acuity (BCVA)

Drug: T1695

Diagnostic Test: Corneal fluorescein staining score on modified Oxford scale

Ciclosporin

Active Comparator group

Description:

The participant should instill Ciclosporin.

Treatment:

Drug: Ciclosporin

Diagnostic Test: Slit Lamp Examination

Diagnostic Test: Far Best Corrected Visual Acuity (BCVA)

Diagnostic Test: Corneal fluorescein staining score on modified Oxford scale