Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis
Condition: Vernal Keratoconjunctivitis
MeSH terms: Keratoconjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      This interventional study aims to evaluate the efficacy of Cyclosporine eye drop treatment in
      preventing relapses of Vernal Keratoconjunctivitis (VKC) and in treating the acute phases of
      the disease.
    

Detailed description: 
      Vernal keratoconjunctivitis (VKC) is a severe allergic disease, characterised by chronic
      ocular surface inflammation with seasonal relapses. Active phases of VKC require treatment
      with topical steroids to control inflammation and corneal damage that may lead to impairment
      of visual function and severe ocular discomfort. To date, safe and effective therapies in
      preventing relapses and controlling active phases of VKC are not available. Few controlled
      trials have used topical Cyclosporine A (CsA) for the treatment of VKC. The present
      multicenter, double-masked, randomised, controlled clinical trial will allow to obtain
      further data on the safety and efficacy of topical treatment with Cyclosporine in patients
      affected by VKC. Moreover, this study will evaluate the efficacy of topical CsA in both
      preventing the relapses of VKC and controlling the active phases of the disease. It is
      important to highlight that Cyclosporine eye drops are not currently commercially available
      in Italy and must be custom-made by specialized pharmacies. As VKC mostly affects young
      patients, it influences their daily life and their social interactions. Moreover, the severe
      signs and symptoms of the disease result in frequent ophthalmologic controls, influencing
      school activities of children and working days for their parents with a relevant economic
      cost for the National Health System.

      Comparisons: Efficacy of Cyclosporine A 0.05% eye-drops in preventing VKC relapses compared
      to standard antiallergic (Ketotifen fumarate 0.025% eye-drops) treatment, and efficacy of
      Cyclosporine A 0.1% eye-drops in controlling acute phases compared to antiinflammatory
      (Desametasone 0.15% eye drops) treatments.
    

Intervention name(s): Cyclosporine A 0,05% eye drop; ketotifen fumarate 0.025% eye drops
Intervention type(s): Drug; Drug
Intervention description(s): Cyclosporine A 0.05% eye drops will be administered 2 times daily for six months in the first year of the study and in the second year of the study in a cross-over manner(from March to September); ketotifen fumarate 0.025% eye drops 2 times daily for 6 months in the first year of the study (from March to September) and 6 months in the same period in the second year of the study in cross over manner.
Other intervention name(s): NOVA22007; Zaditen collirio monodose
Intervention MeSH terms: Ketotifen; Cyclosporine; Ophthalmic Solutions; Cyclosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vernal keratoconjunctivitis; Cyclosporine; Children; Clinical trial