Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis

This study has been completed.
Sponsor:
Collaborators:
University of Genova
University of Padova
Information provided by:
Campus Bio-Medico University
ClinicalTrials.gov Identifier:
NCT00426023
First received: January 23, 2007
Last updated: January 27, 2009
Last verified: January 2009

January 23, 2007
January 27, 2009
February 2007
October 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
  • 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
  • scores compared to baseline values.
Complete list of historical versions of study NCT00426023 on ClinicalTrials.gov Archive Site
  • Differences of specific symptoms and signs, of TSyS, TSS, Quick questionnaire subscales and biochemical and [ Time Frame: 2 years ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Differences of specific symptoms and signs, of TSyS, TSS, Quick questionnaire subscales and biochemical and
  • molecular parameters will be evaluated at baseline, after 1, 3 and 6 months of treatment and after 1 month of treatment discontinuation.
Not Provided
Not Provided
 
Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Vernal Keratoconjunctivitis
  • 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)
    Other Name: NOVA22007
  • 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.
    Other Name: Zaditen collirio monodose
  • Experimental: 1
    this group of patients is treated with the experimental drug (Cyclosporine A 0,05% eye drops) 2 times daily
    Intervention: Drug: Cyclosporine A 0,05% eye drop
  • Active Comparator: 2
    Intervention: Drug: ketotifen fumarate 0.025% eye drops

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
5 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00426023
eudract 2006-003689-32, FARM5YZTZW, ALMA1
Not Provided
Alessandro Lambiase, University of Rome Campus Bio-Medico
Campus Bio-Medico University
  • University of Genova
  • University of Padova
Principal Investigator: alessandro lambiase, MD University of Rome Campus Bio-Medico
Campus Bio-Medico University
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP