Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis

This study has been completed.
Sponsor:
Collaborators:
University of Genova
University of Padova
Information provided by:
Campus Bio-Medico University
ClinicalTrials.gov Identifier:
NCT00426023
First received: January 23, 2007
Last updated: January 27, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Vernal Keratoconjunctivitis
Drug: Cyclosporine A 0,05% eye drop
Drug: ketotifen fumarate 0.025% eye drops
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Campus Bio-Medico University:

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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences of specific symptoms and signs, of TSyS, TSS, Quick questionnaire subscales and biochemical and [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: February 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   5 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426023

Locations
Italy
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
Investigators
Principal Investigator: alessandro lambiase, MD University of Rome Campus Bio-Medico
  More Information

Publications:

Responsible Party: Alessandro Lambiase, University of Rome Campus Bio-Medico
ClinicalTrials.gov Identifier: NCT00426023     History of Changes
Other Study ID Numbers: eudract 2006-003689-32, FARM5YZTZW, ALMA1
Study First Received: January 23, 2007
Last Updated: January 27, 2009
Health Authority: Italy: Ethics Committee
Italy: Agenzia Italiana del Farmaco- AIFA

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

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Keratoconjunctivitis
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Keratitis
Cyclosporine
Cyclosporins
Ketotifen
Ophthalmic Solutions
Tetrahydrozoline
Anti-Allergic Agents
Anti-Infective Agents
Antifungal Agents
Antipruritics
Antirheumatic Agents
Autonomic Agents
Cardiovascular Agents
Dermatologic Agents
Enzyme Inhibitors
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 29, 2014