3% Diquafosol Ophthalmic Solution for Active Moderate-to-Severe Vernal Keratoconjunctivitis
Recruiting
Phase 3
Interventional Study
Vernal Keratoconjunctivitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 94 (estimated)
- Sponsor
- The University of Hong Kong · Other
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About This Trial
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 wou…
Trial Locations
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Eligibility Criteria
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 th…
Contacts