RecruitingPhase 3NCT06903884

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

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


Sponsor

The University of Hong Kong

Enrollment

94 participants

Start Date

Feb 9, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 0.1% Cyclosporin A cationic ophthalmic emulsion and a drug called 3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion for people with vernal keratoconjunctivitis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion

This arm is to investigate whether patients with moderate-to-severe VKC and keratitis will benefit from the addition of Diquafosol ophthalmic solution

DRUG0.1% Cyclosporin A cationic ophthalmic emulsion

This arm is a control group to investigate whether patients with moderate-to-severe VKC and keratitis will benefit from the addition of Diquafosol ophthalmic solution


Locations(1)

HKU Eye Centre

Hong Kong, Hong Kong

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NCT06903884