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

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.

Timeline

Start

2013-04-29

Primary completion

2016-02

Completion

2016-02

Outcome

Met primary endpoint

registry analysis (superiority test); High Dose Regimen vs Placebo; p = 0.007; LS Mean 0.76 (95% CI 0.26 to 1.27); NCT01751126 ↗

registry analysis (superiority test); Low Dose Regimen vs Placebo; p = 0.010; LS Mean 0.67 (95% CI 0.16 to 1.18); NCT01751126 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclosporine	Peptide	1 mg/ml	Other

Indications