NCT06903884 3% Diquafosol Ophthalmic Solution for Active Moderate-to-Severe Vernal Keratoconjunctivitis
| NCT ID | NCT06903884 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The University of Hong Kong |
| Condition | Vernal Keratoconjunctivitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2026-02-09 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 94 participants in total. It began in 2026-02-09 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the study is to investigate whether patients with moderate-to-severe VKC and keratitis will benefit from the addition of Diquafosol ophthalmic solution in terms of symptoms and signs of VKC, tear film metrics, ocular surface inflammation and quality of life. Potential beneficial effect of Diquafosol treatment on top of current standard use of topical immunosuppressant therapy in VKC would be studied. Subject at least aged 6 and above with clinical diagnosis of vernal keratoconjunctivitis would be invited to join this study and perform the following assessments: 1. best corrected visual acuity, 2. slit lamp biomicroscope examination, 3. tear meniscus height and non-invasive keratographic tear breakup time(NIKBUT) measurement, 4. cornea fluorescein staining (CFS) and 5. Schirmer's I test. Doctor will prescribe eyedrop, 3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion or 0.1% Cyclosporin A cationic ophthalmic emulsion at the end of examination. Subjects will be followed up at 4 weeks, 8 weeks, 16 weeks after treatment. All participants will be required to answer a standardised questionnaire relating to severity of VKC and dry eye disease.
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
Contact & Investigator
Kendrick Co Shih
PRINCIPAL INVESTIGATOR
The University of Hong Kong, Grantham Hospital
Frequently Asked Questions
Who can join the NCT06903884 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Vernal Keratoconjunctivitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06903884 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 94 participants.
Is NCT06903884 currently recruiting?
Yes, NCT06903884 is actively recruiting participants. Contact the research team at kcshih@hku.hk for enrollment information.
Where is the NCT06903884 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06903884 clinical trial?
NCT06903884 is sponsored by The University of Hong Kong. The principal investigator is Kendrick Co Shih at The University of Hong Kong, Grantham Hospital. The trial plans to enroll 94 participants.