Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis

NCT00426023 | Completed Phase 3

• 3 other identifiers: eudract 2006-003689-32FARM5YZTZWALMA1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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.

Conditions

Vernal Keratoconjunctivitis

Keywords

Vernal keratoconjunctivitis; Cyclosporine; Children; Clinical trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Differences of specific symptoms and signs, of TSyS, TSS, Quick questionnaire subscales and biochemical and

  2 years

• molecular parameters will be evaluated at baseline, after 1, 3 and 6 months of treatment and after 1 month of treatment discontinuation

  2 years

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Cyclosporine A 0,05% eye drop

2

ACTIVE COMPARATOR

Drug: ketotifen fumarate 0.025% eye drops

Interventions

Cyclosporine A 0,05% eye drop 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)

Also known as: NOVA22007

1

ketotifen fumarate 0.025% eye drops 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.

Also known as: Zaditen collirio monodose

2

Eligibility Criteria

• Age: 5 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Campus Bio-Medico University: lead
• University of Genova: collaborator
• University of Padova: collaborator

Study Sites (3)

University of Rome Campus Bio-Medico

Rome, Rome, 00155, Italy

Location

University of Genova

Genova, Italy

Location

University of Padua

Padua, Italy

Location

Related Publications (9)

• 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.

  PMID: 10857837 BACKGROUND

• 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.

  PMID: 14501439 BACKGROUND

• 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.

  PMID: 1337745 BACKGROUND

• 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.

  PMID: 16023216 BACKGROUND

• 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.

  PMID: 9246280 BACKGROUND

• 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.

  PMID: 2248328 BACKGROUND

• 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.

  PMID: 11318292 BACKGROUND

• 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.

  PMID: 3953723 BACKGROUND

• 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.

  PMID: 12052387 BACKGROUND

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Ketotifen; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• alessandro lambiase, MD

  University of Rome Campus Bio-Medico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 23, 2007
• First Posted: January 24, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: January 28, 2009

Record last verified: 2009-01

Locations

IT (3)