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

NCT06903884 | Recruiting Phase 3

• 1 other identifier: VKC001
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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. 1.best corrected visual acuity,
2. 2.slit lamp biomicroscope examination,
3. 3.tear meniscus height and non-invasive keratographic tear breakup time(NIKBUT) measurement,
4. 4.cornea fluorescein staining (CFS) and
5. 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.

Conditions

Vernal Keratoconjunctivitis

Keywords

Vernal Keratoconjunctivitis; Dry eye disease; Diquafosol; 0.1% Cyclosporin A

Outcome Measures

Primary Outcomes (1)

• Change in Cornea Fluorescein Staining (CFS) score from baseline to 4 weeks, 8 weeks and 16 weeks between study groups

  Higher values mean inferior outcomes. Graded according to the modified Oxford grading scale (range 0, 0.5, 1, 2, 3, 4, 5). A difference in score of at least 2 levels (i.e. 4 to 2) or complete resolution of staining (i.e. 0) are both considered clinically significant endpoints.

  From baseline to 4 months post- treatment between study groups

Secondary Outcomes (8)

• Percentage of patients requiring rescue topical steroid therapy at 4 weeks, 8 weeks and 16 weeks

  From baseline to 4 months post- treatment between study groups

• Percentage of patients with improvement in Cornea Fluorescein Staining (CSF) at 4 weeks, 8 weeks and 16 weeks

  From baseline to 4 months post- treatment between study groups

• Change in best corrected visual acuity from baseline to 4 weeks, 8 weeks and 16 weeks

  From baseline to 4 months post- treatment between study groups

• Change in Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED) score from baseline to 4 weeks, 8 weeks and 16 weeks

  From baseline to 4 months post- treatment between study groups

• Change in Quality of Life in Children with Vernal Keratoconjunctivitis (QUICK) score from baseline to 4 weeks, 8 weeks and 16 weeks

  From baseline to 4 months post- treatment between study groups

Other Outcomes (3)

• Incidence of ocular adverse events

  From baseline to 4 months post- treatment between study groups

• Incidence of non-ocular adverse events

  From baseline to 4 months post- treatment between study groups

• • Incremental cost-effectiveness ratio (ICER) in cost per quality-adjusted life year (QALYs) gained.

  From baseline to 4 months post- treatment between study groups

Study Arms (2)

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

EXPERIMENTAL

3% Diquafosol eyedrops 6x/day + 0.1% Cyclosporin A twice a day

Drug: 3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion

0.1% Cyclosporin A cationic ophthalmic emulsion

ACTIVE COMPARATOR

0.1% Cyclosporin A eyedrops twice a day + preservative free sodium hyaluronate eyedrops 6x/day

Drug: 0.1% Cyclosporin A cationic ophthalmic emulsion

Interventions

3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion DRUG

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

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

0.1% Cyclosporin A cationic ophthalmic emulsion DRUG

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

0.1% Cyclosporin A cationic ophthalmic emulsion

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

HKU Eye Centre

Hong Kong, Hong Kong

RECRUITING

Related Publications (39)

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MeSH Terms

Conditions

Conjunctivitis, Allergic; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lacrimal Apparatus Diseases

Study Officials

• Kendrick Co Shih

  The University of Hong Kong, Grantham Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kendrick Co Shih

CONTACT

39621412; kcshih@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: It is a double-masked randomized study. Assigned treatment of a specific patients would be kept confidential in both the recruited participants and investigators. To keep the investigators and subjects blind to the study treatment, all investigational drugs are removed from their commercial packaging, wrapped in aluminium foil, double-wrapped in plastic bags, and distributed to participants by an independent clinical research coordinator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group of subjects will receive topical treatment with 3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion; another group of subjects will receive 0.1% Cyclosporin A cationic ophthalmic emulsion

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: February 9, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 30, 2026

Record last verified: 2025-04

Locations

HK (1)