Actively Recruiting
3% Diquafosol Ophthalmic Solution for Active Moderate-to-Severe Vernal Keratoconjunctivitis
Led by The University of Hong Kong · Updated on 2026-04-30
94
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
3% Diquafosol Ophthalmic Solution for Active Moderate-to-Severe Vernal Keratoconjunctivitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject at least aged 6 and above
- Clinical diagnosis of vernal keratoconjunctivitis
- Active moderate-to-severe VKC with at least Grade 2 on the Bonini scale
- Presence of keratitis with at least Grade 1 cornea fluorescein staining on the Modified Oxford scale
- Experienced one or more VKC recurrences in the previous year
You will not qualify if you...
- Nasolacrimal duct obstruction
- Impaired blinking function
- Active ocular infection or history of ocular herpes, varicella zoster, or vaccinia virus infection
- Any ocular disease requiring topical treatment during the study
- Use of cyclosporin A, tacrolimus eyedrops, or systemic immunosuppressants within 3 months before enrollment
- Any ocular surgery within 6 months before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
HKU Eye Centre
Hong Kong, Hong Kong
Actively Recruiting
Research Team
K
Kendrick Co Shih
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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