3% Diquafosol Ophthalmic Solution for Active Moderate-to-Severe Vernal Keratoconjunctivitis

Launched by THE UNIVERSITY OF HONG KONG · Mar 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new eye drop called 3% Diquafosol to see if it can help patients aged 6 and older who have moderate to severe Vernal Keratoconjunctivitis (VKC), a condition that causes inflammation and discomfort in the eyes. The goal is to find out if adding Diquafosol to the usual treatment can improve symptoms, reduce inflammation, and enhance quality of life for these patients. To participate, individuals must have a confirmed diagnosis of VKC and have experienced at least one episode of this condition in the past year.

Participants in the trial will receive eye exams and assessments at the beginning of the study and will be prescribed Diquafosol along with another eye drop. They will be followed up over 16 weeks to see how well the treatment works. Throughout the study, participants will also fill out a questionnaire about their symptoms. It's important to note that certain conditions, such as recent eye surgery or infections, may prevent someone from joining the trial. This research aims to provide new insights into treating VKC more effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject at least aged 6 and above
• • Clinical diagnosis of vernal keratoconjunctivitis
• • Evidence of active moderate-to-severe disease: At least Grade 2 on the Bonini scale of VKC clinical presentation (moderate-to-severe) \[38\].
• • Evidence of keratitis: At least Grade 1 on the Modified Oxford scale for cornea fluorescein staining as reported by Bron et al \[39\].
• • Experienced 1 or more recurrences of VKC during the previous year
• Exclusion Criteria:
• • Nasolacrimal duct obstruction
• • Impaired blinking function
• • Active ocular infection or history of ocular herpes, varicella zoster or vaccinia virus infection
• • Any ocular disease that would require topical ocular treatment during the study
• • Use of cyclosporin A or tacrolimus eyedrops, or use of systemic immunosuppressants within 3 months before enrolment
• • Any ocular surgery within 6 months before enrolment