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

NCT ID: NCT07169695

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-02

Study Completion Date

2027-01-21

Brief Summary

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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

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Conditions

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Moderate to Severe Vernal Keratoconjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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T1695

The participant should instill T1695.

Group Type EXPERIMENTAL

Slit Lamp Examination

Intervention Type DIAGNOSTIC_TEST

The participant will have a slit lamp examination

Far Best Corrected Visual Acuity (BCVA)

Intervention Type DIAGNOSTIC_TEST

The participant 's BCVA will be evaluated.

T1695

Intervention Type DRUG

The participant should instill T1695.

Corneal fluorescein staining score on modified Oxford scale

Intervention Type DIAGNOSTIC_TEST

One drop of fluorescein will be instilled to assess the fluorescein staining score on the modified Oxford scale.

Ciclosporin

The participant should instill Ciclosporin.

Group Type ACTIVE_COMPARATOR

Slit Lamp Examination

Intervention Type DIAGNOSTIC_TEST

The participant will have a slit lamp examination

Far Best Corrected Visual Acuity (BCVA)

Intervention Type DIAGNOSTIC_TEST

The participant 's BCVA will be evaluated.

Ciclosporin

Intervention Type DRUG

The participant should instill Ciclosporin.

Corneal fluorescein staining score on modified Oxford scale

Intervention Type DIAGNOSTIC_TEST

One drop of fluorescein will be instilled to assess the fluorescein staining score on the modified Oxford scale.

Interventions

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Slit Lamp Examination

The participant will have a slit lamp examination

Intervention Type DIAGNOSTIC_TEST

Far Best Corrected Visual Acuity (BCVA)

The participant 's BCVA will be evaluated.

Intervention Type DIAGNOSTIC_TEST

T1695

The participant should instill T1695.

Intervention Type DRUG

Ciclosporin

The participant should instill Ciclosporin.

Intervention Type DRUG

Corneal 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoires Thea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Corentin LE CAMUS

Role: CONTACT

+33473981436

Other Identifiers

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2025-521567-12-00

Identifier Type: CTIS

Identifier Source: secondary_id

LT1695-201

Identifier Type: -

Identifier Source: org_study_id

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