Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (VKC)

Summary

The primary objective of this study is: * To assess the efficacy of Nova22007, a cyclosporine A (CsA), 0.05% and 0.1% versus vehicle in patients with vernal keratoconjunctivitis (VKC) after a 4-week treatment period. The secondary objectives of this study are: * To compare the safety and ocular tolerance of Nova22007 0.05% and 0.1%; * To assess the long term safety and ocular tolerance of Nova22007 0.05% and 0.1%; and * To assess the decrease in frequency of concomitant artificial tears use.

Timeline

Start

2006-05

Primary completion

2007-02-22

Completion

—

Outcome

Mixed primary results

paper the primary efficacy end point was not met. PMID 37872059 ↗

registry analysis (superiority test); Vehicle vs NOVA22007 0.05%; p = 0.0386; M-H-Chi-square 4.2925; Cochran-Mantel-Haenszel NCT00328653 ↗

registry analysis (superiority test); Vehicle vs NOVA22007 0.1%; p = 0.0208; M-H-Chi-square 5.3007; Cochran-Mantel-Haenszel NCT00328653 ↗

Publications

• Leonardi A, Pisella PJ, Benitez-Del-Castillo JM, Amrane M, Ismail D, Doan S, Bremond-Gignac D. NOVATIVE: A Phase II/III, Multicenter, Double-masked, Randomized Study of Cyclosporine A 0.05% and 0.1% Ophthalmic Cationic Emulsion Versus Vehicle in Patients with Vernal Keratoconjunctivitis. Clin Ther. 2023 Dec;45(12):1284-1288. doi: 10.1016/j.clinthera.2023.09.022. Epub 2023 Oct 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclosporine	Peptide	0.05 %	Other
Subject	Cyclosporine	Peptide	0.1 %	Other

Indications