NCT01751126

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Santen SAS · Industry
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vernal Keratoconjunctivitis

Interventions

Type	Name	Description
DRUG	NOVA22007 ''Ciclosporin''	Sterile, ophthalmic cationic oil-in-water emulsion containing 1 mg/ml Ciclosporin.
DRUG	Placebo	Sterile, drug-free, cationic ophthalmic oil-in-water emulsion containing 0 mg/ml Ciclosporin.

Timeline

• Start date: 2013-04-29
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2012-12-17
• Last updated: 2022-03-28
• Results posted: 2022-03-28

Locations

46 sites across 11 countries: United States, Croatia, France, Germany, Greece, Hungary, India, Israel, Italy, Portugal, Spain