CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 48 target
Drug / intervention
Cyclosporine A 0,05% eye drop +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00426023
NCT00426023Phase 3Completed
CompareCT.gov

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.

Campus Bio-Medico University·interventional·Posted Jan 24, 2007·Updated Jan 28, 2009

In Brief

A Phase 3 clinical trial evaluating Cyclosporine A 0,05% eye drop and ketotifen fumarate 0.025% eye drops for Vernal Keratoconjunctivitis. Completed, enrolled 48 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVernal Keratoconjunctivitis
CountriesItaly
CollaboratorsUniversity of Genova, University of Padova

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 24, 2007
Enrollment StartFeb 1, 2007
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.4 years ago

Interventions

Cyclosporine A 0,05% eye dropdrug

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)

ketotifen fumarate 0.025% eye dropsdrug

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.