Status:
NOT_YET_RECRUITING
3% Diquafosol Ophthalmic Solution for Active Moderate-to-Severe Vernal Keratoconjunctivitis
Lead Sponsor:
The University of Hong Kong
Conditions:
Vernal Keratoconjunctivitis
Eligibility:
All Genders
6+ years
Phase:
PHASE3
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...
Detailed Description
Aim To compare the four-month clinical efficacy of topical treatment with 3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion versus 0.1% Cyclosporin A cationic ophth...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT06903884
Start Date
December 30 2025
End Date
December 31 2028
Last Update
September 19 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.