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

Recruiting now · Phase 3

Conditions studied: Vernal Keratoconjunctivitis

In brief

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.

Key facts

Study ID

NCT06903884

Run by

The University of Hong Kong

People needed

94

Starts

2026-02-09

Expected to finish

2028-12-31

Last updated by the study team

2026-04-30

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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