Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis

Vernal Keratoconjunctivitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426023
• Other study ID #: eudract 2006-003689-32
• Secondary ID: FARM5YZTZWALMA1
• Status: Completed
• Phase: Phase 3
• First received: January 23, 2007
• Last updated: January 27, 2009
• Start date: February 2007
• Est. completion date: October 2008

Study information

• Verified date: January 2009
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: Agenzia Italiana del Farmaco- AIFA
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis, Allergic
• Keratoconjunctivitis
• Vernal Keratoconjunctivitis

Intervention

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)
• 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.

Locations

Country	Name	City	State
Italy	University of Genova	Genova
Italy	University of Padua	Padua
Italy	University of Rome Campus Bio-Medico	Rome

Sponsors (3)

Lead Sponsor	Collaborator
Campus Bio-Medico University	University of Genova, University of Padova

Country where clinical trial is conducted

Italy, 

References & Publications (9)

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. — View Citation

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 (Lond). 1992;6 ( Pt 6):648-52. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Gupta V, Sahu PK. Topical cyclosporin A in the management of vernal keratoconjunctivitis. Eye (Lond). 2001 Feb;15(Pt 1):39-41. — View Citation

Leonardi A. Vernal keratoconjunctivitis: pathogenesis and treatment. Prog Retin Eye Res. 2002 May;21(3):319-39. Review. — View Citation

Mendicute J, Aranzasti C, Eder F, Ostolaza JI, Salaberria M. Topical cyclosporin A 2% in the treatment of vernal keratoconjunctivitis. Eye (Lond). 1997;11 ( Pt 1):75-8. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 years	No
Secondary	Differences of specific symptoms and signs, of TSyS, TSS, Quick questionnaire subscales and biochemical and		2 years	No
Secondary	molecular parameters will be evaluated at baseline, after 1, 3 and 6 months of treatment and after 1 month of treatment discontinuation		2 years	No