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

April 21, 2026 updated by: Laboratoires Thea

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
      • Ahmedabad, India
        • Recruiting
        • Netralaya Super Speciality Eye Hospital
      • Ahmedabad, India
        • Recruiting
        • M&J Institute of Ophthalmology
      • Bangalore, India
        • Recruiting
        • Narayana Nethralaya
      • Hyderabad, India
        • Recruiting
        • L. V. Prasad Eye Institute (LVPEI)
      • Jaipur, India
        • Recruiting
        • Agrawal Hospital
      • Kolkata, India
        • Recruiting
        • Regional Institute of Ophthalmology (RIO) - Kolkata
      • Patna, India
        • Recruiting
        • Regional Institute of Ophthalmology, Patna
      • Pune, India
        • Recruiting
        • PBMA'S H. V. Desai Eye Hospital
      • Surat, India
        • Recruiting
        • Shivam Retina Clinic and Eye Hospital
      • Visakhapatnam, India
        • Recruiting
        • L V Prasad Eye Institute
    • West Bengal
      • Kolkata, West Bengal, India
        • Recruiting
        • Disha Eye Hospitals - Barrackpore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T1695
The participant should instill T1695.
Diagnostic test: Slit Lamp Examination
The participant will have a slit lamp examination
Diagnostic test: Far Best Corrected Visual Acuity (BCVA)
The participant 's BCVA will be evaluated.
Drug: T1695
The participant should instill T1695.
Diagnostic test: 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.
Active Comparator: Ciclosporin
The participant should instill Ciclosporin.
Diagnostic test: Slit Lamp Examination
The participant will have a slit lamp examination
Diagnostic test: Far Best Corrected Visual Acuity (BCVA)
The participant 's BCVA will be evaluated.
Diagnostic test: 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.
Drug: Ciclosporin
The participant should instill Ciclosporin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From Day 1 to Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2026

Primary Completion (Estimated)

January 21, 2027

Study Completion (Estimated)

January 21, 2027

Study Registration Dates

First Submitted

September 5, 2025

First Submitted That Met QC Criteria

September 5, 2025

First Posted (Actual)

September 12, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT1695-201
  • 2025-521567-12-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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