Official Title: “Multicenter, Randomised, Double Masked, Controlled Studies on the Efficacy of Cyclosporine Eye Drop Treatment in Preventing Vernal Keratoconjunctivitis (VKC) Relapses and in Treating the Acute Phase.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2008

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(s) in this Clinical Trial

• Drug: Cyclosporine A 0,05% eye drop
  • 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)
• Drug: ketotifen fumarate 0.025% eye drops
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • this group of patients is treated with the experimental drug (Cyclosporine A 0,05% eye drops) 2 times daily
• Active Comparator: 2

Primary Measures

• To compare the number of relapses of ocular inflammation per year between cyclosporine and ketotifen treated groups. Relapses are defined as at least 100% increase of the sum of hyperemia, itching, Trantas dots and corneal involvement
  • Time Frame: 2 years
    Safety Issue?: No

Secondary Measures

• Differences of specific symptoms and signs, of TSyS, TSS, Quick questionnaire subscales and biochemical and
  • Time Frame: 2 years
    Safety Issue?: No
• molecular parameters will be evaluated at baseline, after 1, 3 and 6 months of treatment and after 1 month of treatment discontinuation
  • Time Frame: 2 years
    Safety Issue?: No

Inclusion Criteria:

• Patients affected by VKC will be enrolled by the three Centres involved in the project
• Diagnosis of VKC will be performed on the basis of personal and family history of systemic allergic diseases, clinical examination (presence of conjunctival tarsal and/or limbal papillae) and presence of eosinophils in the conjunctival scraping

Exclusion Criteria:

• Contact lens wearers
• Patients affected by other ocular diseases
• Patients subjected to ocular surgery in the preceding 6 months
• Patients under eye drop or systemic treatments for other diseases, or
• Patients enrolled in experimental trials in the preceding 6 months

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 5 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Campus Bio-Medico University

Overall Clinical Trial Officials and Contacts

alessandro lambiase, MD Principal Investigator University of Rome Campus Bio-Medico  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00426023

Study ID Number: eudract 2006-003689-32

ClinicalTrials.gov Identifier: NCT00426023

Health Authority: Italy: Ethics Committee