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Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis

NCT00426023 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2009-01-28

No results posted yet for this study

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.

Conditions

  • Vernal Keratoconjunctivitis

Interventions

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)

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.

Sponsors & Collaborators

  • University of Genova

    collaborator OTHER

  • University of Padova

    collaborator OTHER

  • Campus Bio-Medico University

    lead OTHER

Principal Investigators

  • alessandro lambiase, MD · University of Rome Campus Bio-Medico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00426023 on ClinicalTrials.gov