NCT00328653

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

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Santen SAS · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Conjunctivitis, Vernal

Interventions

Type	Name	Description
DRUG	Cyclosporine NOVA22007 0.05%
DRUG	Cyclosporine NOVA22007 0.1%
DRUG	Vehicle

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-02-22
• First posted: 2006-05-22
• Last updated: 2021-12-14
• Results posted: 2021-12-14

Locations

1 site across 1 country: France