3% Diquafosol plus 0.1% cyclosporin for active moderate-to-severe vernal keratoconjunctivitis with keratitis

A Randomized Controlled Trial of 3% Diquafosol Ophthalmic Solution for Active Moderate-to-Severe Vernal Keratoconjunctivitis

This trial will test whether adding 3% Diquafosol eye drops to 0.1% cyclosporin helps people aged 6 and older who have active moderate-to-severe vernal keratoconjunctivitis with corneal staining.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 94 (estimated)
• Ages: 6 Years and up
• Sex: All
• Sponsor: The University of Hong Kong (Academic / other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT06903884 on ClinicalTrials.gov

What this trial studies

This single-centre, randomized, double-blind phase 3 trial at the HKU Eye Centre will enroll patients aged 6 and above with active moderate-to-severe VKC and corneal fluorescein staining and randomize them to 3% Diquafosol plus 0.1% cyclosporin A emulsion versus 0.1% cyclosporin A emulsion alone for 16 weeks. Primary clinical measures include VKC symptoms and signs and corneal staining, while secondary measures include tear film metrics (tear meniscus height, NIKBUT, Schirmer I) and quality of life. The study will also track longitudinal changes in tear cytokines to explore relationships with clinical response. Visits include baseline and scheduled follow-ups with BCVA, slit-lamp exam, tear measurements, corneal fluorescein staining and Schirmer testing.

Who should consider this trial

Good fit: Ideal candidates are people aged 6 or older with a clinical diagnosis of VKC who have active moderate-to-severe disease (Bonini grade ≥2), evidence of keratitis (modified Oxford corneal staining grade ≥1), and at least one recurrence in the past year.

Not a fit: Patients with mild VKC, other ocular diseases requiring topical treatment, recent ocular surgery, active ocular infection, nasolacrimal duct obstruction, impaired blinking, or recent use of cyclosporin/tacrolimus or systemic immunosuppressants are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, adding diquafosol could improve symptoms, corneal staining, tear-film stability, and reduce ocular surface inflammation beyond cyclosporin alone.

How similar studies have performed: Diquafosol has demonstrated benefits for tear film and ocular surface measures in dry eye studies, but high-quality randomized data specifically in VKC and in combination with cyclosporin are limited, so this approach is relatively novel for VKC.

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

Where this trial is running

Hong Kong

• HKU Eye Centre — Hong Kong, Hong Kong (Recruiting)

Study contacts

• Principal investigator: Kendrick Co Shih — The University of Hong Kong, Grantham Hospital
• Study coordinator: Kendrick Co Shih

Conditions Vernal Keratoconjunctivitis; Dry eye disease; Diquafosol; 0.1% Cyclosporin A