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NCT Number: NCT07169695

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

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

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Key information

Conditions

Moderate to Severe Vernal Keratoconjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Disha Eye Hospitals - Barrackpore, Kolkata, West Bengal, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Corentin LE CAMUS

CONTACT

[email protected]

+33473981436

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Official study title

Efficacy and Safety Assessment of T1695 Ophthalmic Suspension, Versus Ciclosporin Ophthalmic Emulsion, in Participants With Moderate to Severe Vernal Keratoconjunctivitis (VKC)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 12, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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