Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis

NCT ID: NCT00426023

Last Updated: 2009-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-10-31

Brief 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.

Conditions

Vernal Keratoconjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

this group of patients is treated with the experimental drug (Cyclosporine A 0,05% eye drops) 2 times daily

Group Type: EXPERIMENTAL

Cyclosporine A 0,05% eye drop

Intervention Type: DRUG

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)

2

Group Type: ACTIVE_COMPARATOR

ketotifen fumarate 0.025% eye drops

Intervention Type: DRUG

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.

Interventions

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)

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

NOVA22007; Zaditen collirio monodose

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Genova

OTHER

Sponsor Role: collaborator

University of Padova

OTHER

Sponsor Role: collaborator

Campus Bio-Medico University

OTHER

Sponsor Role: lead

Responsible Party

University of Rome Campus Bio-Medico

Principal Investigators

alessandro lambiase, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rome Campus Bio-Medico

Locations

University of Rome Campus Bio-Medico

Rome, Rome, Italy

University of Genova

Genova, , Italy

University of Padua

Padua, , Italy

Countries

Italy

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. doi: 10.1016/s0161-6420(00)00092-0.

Reference Type: BACKGROUND

PMID: 10857837 (View on PubMed)

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. doi: 10.1097/00130832-200310000-00011.

Reference Type: BACKGROUND

PMID: 14501439 (View on PubMed)

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. doi: 10.1038/eye.1992.139.

Reference Type: BACKGROUND

PMID: 1337745 (View on PubMed)

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. doi: 10.1016/j.ophtha.2005.04.009.

Reference Type: BACKGROUND

PMID: 16023216 (View on PubMed)

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. doi: 10.1038/eye.1997.14.

Reference Type: BACKGROUND

PMID: 9246280 (View on PubMed)

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. doi: 10.1016/s0002-9394(14)77061-8.

Reference Type: BACKGROUND

PMID: 2248328 (View on PubMed)

Gupta V, Sahu PK. Topical cyclosporin A in the management of vernal keratoconjunctivitis. Eye (Lond). 2001 Feb;15(Pt 1):39-41. doi: 10.1038/eye.2001.10.

Reference Type: BACKGROUND

PMID: 11318292 (View on PubMed)

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. doi: 10.1016/0002-9394(86)90819-6.

Reference Type: BACKGROUND

PMID: 3953723 (View on PubMed)

Leonardi A. Vernal keratoconjunctivitis: pathogenesis and treatment. Prog Retin Eye Res. 2002 May;21(3):319-39. doi: 10.1016/s1350-9462(02)00006-x.

Reference Type: BACKGROUND

PMID: 12052387 (View on PubMed)

Other Identifiers

FARM5YZTZW

Identifier Type: -

Identifier Source: secondary_id

ALMA1

Identifier Type: -

Identifier Source: secondary_id

eudract 2006-003689-32

Identifier Type: -

Identifier Source: org_study_id