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

Vernal Keratoconjunctivitis Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01751126
Study type	Interventional
Source	Santen SAS
Contact
Status	Completed
Phase	Phase 3
Start date	April 29, 2013
Completion date	February 2016

View Details

See also
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Completed	`NCT01211327` - Topical Cyclosporine for Vernal Keratoconjunctivitis (VKC) in Rwanda	Phase 4
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Not yet recruiting	`NCT04705584` - Topical Immuonosuppressant Drugs in Spring Catarrh	N/A
Completed	`NCT03379311` - A Study of AK002 in Patients With Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, and Perennial Allergic Conjunctivitis	Phase 1
Completed	`NCT00426023` - Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis	Phase 3
Recruiting	`NCT02456025` - Topical Tacrolimus in Vernal Keratoconjunctivitis	Phase 4