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

NCT07169695 · tracked via the Priya Life Science India tracker

Sponsor

Laboratoires Thea

Phase

Phase 2

Started

2026-03-24

Last updated

2026-04-22

Condition(s) studied

Moderate to Severe Vernal Keratoconjunctivitis

Investigational drug(s) / intervention(s)

Slit Lamp ExaminationFar Best Corrected Visual Acuity (BCVA)T1695CiclosporinCorneal fluorescein staining score on modified Oxford scale

Slit Lamp Examination: The participant will have a slit lamp examination

Far Best Corrected Visual Acuity (BCVA): The participant 's BCVA will be evaluated.

T1695: The participant should instill T1695.

Ciclosporin: The participant should instill Ciclosporin.

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.

Study summary

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

Eligibility

Sex

ALL

Min age

4 Years

Max age

17 Years

Healthy volunteers

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.

Primary outcome measure(s)

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. — From Day 1 to Day 29

Trial sites (11)

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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07169695 on ClinicalTrials.gov ↗ ← All trials in India