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...
Date First Received: January 23, 2007
Last Updated: March 7, 2007
Verified by: Campus Bio-Medico University, March 2007
Clinical Trial Phase: Phase 3 | Start Date: February 2007
Overall Status: Recruiting
Estimated Enrollment: 48
Brief Summary
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.”
Condition Keyword(s):
Intervention(s):
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, Active Control, Crossover Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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(s) in this Clinical Trial
- Drug: cyclosporin eye drop
Outcome Measures for this Clinical Trial
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
- scores compared to baseline values.
Secondary Measures
- 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.
Criteria for Participation in this Clinical Trial
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 undereye 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
Clinical Trial Sponsor Information
Lead Sponsor: Campus Bio-Medico University
Overall Clinical Trial Officials and Contacts
alessandro lambiase, MD Principal Investigator University of Rome Campus Bio-Medico
Overall Contact: lambiase alessandro, MD PhD 0622541342 a.lambiase@unicampus.it
Related Publications
References
Bonini S, Bonini S, Lambiase A, Marchi S, Pasqualetti P, Zuccaro O, Rama P, Magrini L, Juhas T, Bucci MG. Vernal keratoconjunctivitis revisited: a case series of 195 patients with long-term followup. Ophthalmology. 2000 Jun;107(6):1157-63.
Bonini S, Lambiase A, Sgrulletta R, Bonini S. Allergic chronic inflammation of the ocular surface in vernal keratoconjunctivitis. Curr Opin Allergy Clin Immunol. 2003 Oct;3(5):381-7. Review.
Bonini S, Barney NP, Schiavone M, Centofanti M, Berruto A, Bonini S, Allansmith MR. Effectiveness of nedocromil sodium 2% eyedrops on clinical symptoms and tear fluid cytology of patients with vernal conjunctivitis. Eye. 1992;6 ( Pt 6):648-52.
Bonini S, Micera A, Iovieno A, Lambiase A, Bonini S. Expression of Toll-like receptors in healthy and allergic conjunctiva. Ophthalmology. 2005 Sep;112(9):1528; discussion 1548-9.
Mendicute J, Aranzasti C, Eder F, Ostolaza JI, Salaberria M. Topical cyclosporin A 2% in the treatment of vernal keratoconjunctivitis. Eye. 1997;11 ( Pt 1):75-8.
Secchi AG, Tognon MS, Leonardi A. Topical use of cyclosporine in the treatment of vernal keratoconjunctivitis. Am J Ophthalmol. 1990 Dec 15;110(6):641-5.
Gupta V, Sahu PK. Topical cyclosporin A in the management of vernal keratoconjunctivitis. Eye. 2001 Feb;15(Pt 1):39-41.
BenEzra D, Pe'er J, Brodsky M, Cohen E. Cyclosporine eyedrops for the treatment of severe vernal keratoconjunctivitis. Am J Ophthalmol. 1986 Mar 15;101(3):278-82.
Leonardi A. Vernal keratoconjunctivitis: pathogenesis and treatment. Prog Retin Eye Res. 2002 May;21(3):319-39. Review.
Additional Information
Information obtained from ClinicalTrials.gov on January 08, 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
Clinical Trials Authorship and Review
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