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NCT Number: NCT00426023

Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis

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.

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Key information

Conditions

Vernal Keratoconjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

5 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Rome Campus Bio-Medico, Rome, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: NOVA22007

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.

Other names: Zaditen collirio monodose

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

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 2 years

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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Collaborators

  • University of Genova
  • University of Padova

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 24, 2007
Registry last updated
Jan 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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