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

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 30, 2025 to Feb 9, 2026
    v4
  2. Start date: Jun 30, 2025 to Dec 30, 2025v3
  3. Primary endpoint revised
    • Secondary endpoints revised (8)
    • Study description shortened, about 1 word
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06903884
Lead Sponsor The University of Hong Kong
Conditions
(from sponsor)		 Vernal Keratoconjunctivitis
Related terms Conjunctivitis, Allergic, Dry Eye Syndromes
Enrollment 94 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov