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Sponsored by: |
Novagali Pharma |
Information provided by: | Novagali Pharma |
ClinicalTrials.gov Identifier: | NCT00328653 |
The primary objective of this study is:
The secondary objectives of this study are:
Condition | Intervention | Phase |
Conjunctivitis, Vernal |
Drug: cyclosporine |
Phase II Phase III |
ChemIDplus related topics: | Cyclosporine Cyclosporin |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 4 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At least the two following signs, in at least one eye* (the same eye should fulfill both criteria):
Exclusion Criteria:
France | |||||
Groupe Hospitalier Bichat-Claude Bernard | |||||
Paris, France, 75018 |
Novagali Pharma |
Principal Investigator: | David BenEzra, Pf | Haddassah University Hospital |
Study Director: | Christophe Baudoin, Pf. | Hôpital des XV-XX 28 rue de Charenton 75012 Paris |
Study ID Numbers: | NOVATIVE - NVG05L101 |
First Received: | May 19, 2006 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00328653 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Italy: The Italian Medicines Agency; Spain: Spanish Agency of Medicines; Turkey: Ministry of Health; Israel: Israeli Health Ministry Pharmaceutical Administration; Morocco: Ministry of Public Health |
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