A Study to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants With Moderate to Severe Vernal Keratoconjunctivitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Slit Lamp Examination, Far Best Corrected Visual Acuity (BCVA), T1695, Ciclosporin.
- Who it may be relevant to
- Registry conditions: Moderate to Severe Vernal Keratoconjunctivitis. Basic parameters: 4 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety Assessment of T1695 Ophthalmic Suspension, Versus Ciclosporin Ophthalmic Emulsion, in Participants With Moderate to Severe Vernal Keratoconjunctivitis (VKC)
Overview
The aim of the study is to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants with Moderate to Severe Vernal Keratoconjunctivitis
Interventions
- 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. - Drug Ciclosporin
The participant should instill Ciclosporin. - 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.
Primary outcome measures
- 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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
India · 11 centers
- Disha Eye Hospitals - Barrackpore — Kolkata
- M&J Institute of Ophthalmology — Ahmedabad
- Netralaya Super Speciality Eye Hospital — Ahmedabad
- Narayana Nethralaya — Bangalore
- L. V. Prasad Eye Institute (LVPEI) — Hyderabad
- Agrawal Hospital — Jaipur
- Regional Institute of Ophthalmology (RIO) - Kolkata — Kolkata
- Regional Institute of Ophthalmology, Patna — Patna
- … and 3 more centers
Identifiers
NCT: NCT07169695 · LT1695-201 · 2025-521567-12-00