3% Diquafosol plus 0.1% cyclosporin for active moderate-to-severe vernal keratoconjunctivitis with keratitis
Official title: A Randomized Controlled Trial of 3% Diquafosol Ophthalmic Solution for Active Moderate-to-Severe Vernal Keratoconjunctivitis
Run by The University of Hong Kong · NCT06903884 · Data updated 2026-11-12
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 |
| Ages | 6 Years and up |
| Sex | All |
| Enrollment | 94 (estimated) |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Status | Recruiting |
| Started | February 9, 2026 |
| Main results expected | June 30, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT06903884 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: kcshih@hku.hk
- Phone: 39621412
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
T1695 versus ciclosporin for moderate to severe vernal keratoconjunctivitis in children and teenagers
This study will test whether T1695 eye treatment works better and is as safe as ciclosporin for kids and teens (ages 4–17) with moderate to severe vernal keratoconjunctivitis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.