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

Conjunctivitis, Vernal Clinical Trial

Official title: Phase II/III, Multicenter, Double-Masked, Randomized, Parallel Group, Dose Ranging, Controlled Trial of Efficacy and Tolerance of Nova22007 (Cyclosporine A [CSA] 0.05% & 0.1% Ophthalmic Cationic Emulsion) Versus Vehicle in Patients With VKC

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic
• Conjunctivitis, Vernal
• Keratoconjunctivitis

• NCT number: NCT00328653
• Study type: Interventional
• Source: Santen SAS
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2006