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

NCT06903884 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

  • Vernal Keratoconjunctivitis

Interventions

DRUG

3% 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

DRUG

0.1% 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

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Kendrick Co Shih · The University of Hong Kong, Grantham Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-09
Primary Completion
2028-06-30
Completion
2028-12-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06903884 on ClinicalTrials.gov