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

RecruitingPhase 3Ages 6 Years - anyAllThe University of Hong Kong
NCT06903884 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 c

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📋 Eligibility rules (as published)
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
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What it tests

  • 3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion
  • 0.1% Cyclosporin A cationic ophthalmic emulsion
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Where

1 site
HKU Eye Centre
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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