Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis

Campus Bio-Medico University of Rome

Status and phase: Completed; Phase 3

Conditions: Vernal Keratoconjunctivitis

Treatments: Drug: ketotifen fumarate 0.025% eye drops; Drug: Cyclosporine A 0,05% eye drop

Study type: Interventional

Funder types: Other

Identifiers

NCT00426023

FARM5YZTZW

ALMA1

eudract 2006-003689-32

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 5 to 50 years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: Cyclosporine A 0,05% eye drop

2

Active Comparator group

Treatment:

Drug: ketotifen fumarate 0.025% eye drops