Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis

Sponsor

Campus Bio-Medico University (Other)

Overall Status

Completed

CT.gov ID

NCT00426023

Collaborator

University of Genova (Other), University of Padova (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vernal Keratoconjunctivitis	Drug: Cyclosporine A 0,05% eye drop Drug: ketotifen fumarate 0.025% eye drops	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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 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 Names: NOVA22007
Active Comparator: 2	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 Names: Zaditen collirio monodose

Arm

Intervention/Treatment

Experimental: 1

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

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 Names:

NOVA22007

Active Comparator: 2

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 Names:

Zaditen collirio monodose

Outcome Measures

Primary Outcome 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 [2 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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