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Clinical trial

Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis

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Last updated:1st Mar 2013
Identifier: NCT01751126

The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe vernal keratoconjunctivitis after 4 months of treatment.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Masked, 3 Parallel Arms, Placebo Controlled Study to Assess the Efficacy and Safety of NOVA22007 1mg/mL (Ciclosporin/Cyclosporine) Eye Drops, Emulsion Administered in Paediatric Patients With Active Severe Vernal Keratoconjunctivitis With Severe Keratitis
Study Start Date: March 2013
Actual Primary Completion Date: February 2016
Actual Study Completion Date: February 2016

Arm:
- Experimental:
Ciclosporin
- Experimental: Ciclosporin/Placebo
- Placebo Comparator: Placebo

Category Value
Date last updated at source 2017-10-06
Study type(s) Interventional
Expected enrolment 169
Study start date 2013-03-01
Estimated primary completion date 2016-02-01

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