Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00426023
Recruitment Status : Completed
First Posted : January 24, 2007
Last Update Posted : January 28, 2009
University of Genova
University of Padova
Information provided by:
Campus Bio-Medico University

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 Type : Interventional  (Clinical Trial)
Estimated 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 : February 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

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 Name: 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 Name: Zaditen collirio monodose

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00426023

University of Genova
Genova, Italy
University of Padua
Padua, Italy
University of Rome Campus Bio-Medico
Rome, Italy, 00155
Sponsors and Collaborators
Campus Bio-Medico University
University of Genova
University of Padova
Principal Investigator: alessandro lambiase, MD University of Rome Campus Bio-Medico


Responsible Party: Alessandro Lambiase, University of Rome Campus Bio-Medico Identifier: NCT00426023     History of Changes
Other Study ID Numbers: eudract 2006-003689-32
First Posted: January 24, 2007    Key Record Dates
Last Update Posted: January 28, 2009
Last Verified: January 2009

Keywords provided by Campus Bio-Medico University:
Vernal keratoconjunctivitis
Clinical trial

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Hypersensitivity, Immediate
Immune System Diseases
Ophthalmic Solutions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants