Comparing the Safety and Effectiveness of T1695 Eye Drops Versus Ciclosporin Eye Drops for Children and Teens with Moderate to Severe Vernal Keratoconjunctivitis

What this Trial Is About

This trial is evaluating the effectiveness and safety of two eye treatments, T1695 and Ciclosporin, in children and teenagers with moderate to severe vernal keratoconjunctivitis, an eye condition causing inflammation. The purpose is to compare these two treatments to see how well they control the disease and how safe they are for participants aged 4 to under 18 years. Participants will be randomly assigned to receive either T1695 ophthalmic suspension or Ciclosporin ophthalmic emulsion. Both treatments involve instilling the medication into the eyes. The study is designed as a single-blind Phase 2 trial to assess and compare these two eye drops over the course of the study. During the trial, participants will undergo eye exams including slit lamp examination and visual acuity testing. Researchers will measure the change in corneal fluorescein staining using a modified Oxford scale from the start of treatment to day 29 week 4 to assess treatment impact. Safety and effectiveness will be closely monitored throughout the study period ending in 2027.

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