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

2014-07-23 21:43:39 | BioPortfolio

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Conditions

Conjunctivitis, Vernal

Intervention

cyclosporine

Location

Groupe Hospitalier Bichat-Claude Bernard
Paris
France
75018

Status

Completed

Source

Novagali Pharma

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:43:39-0400

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