Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Novartis Alcon Laboratories |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00133627 |
Medications available for the treatment of seasonal allergic conjunctivitis include antihistamines. These medicines block the release of histamine, a substance in the body that is released when an allergic reaction occurs. Novartis (NVS) has developed an eye drop formulation of a well tried antihistamine called ketotifen. This study will compare the efficacy and the tolerability of ketotifen eye drops with emedastine, which is a popular treatment for seasonal allergic conjunctivitis in China.
Condition | Intervention | Phase |
---|---|---|
Seasonal Allergic Conjunctivitis |
Drug: Ketotifen |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy Comparison Ketotifen Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis |
Ages Eligible for Study: | 3 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Presence of bilateral ocular itching/conjunctival hyperaemia (redness) at baseline:
Exclusion Criteria:
Other systemic/ophthalmic conditions
Previous treatments
Other protocol-defined inclusion/exclusion criteria may apply
Study ID Numbers: | CZAD511ACN01 |
Study First Received: | August 22, 2005 |
Last Updated: | August 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00133627 |
Health Authority: | China: State Food and Drug Administration |
Allergic Conjunctivitis Ketotifen Histamine |
Hypersensitivity Ketotifen Conjunctivitis, Allergic Eye Diseases Hypersensitivity, Immediate |
Histamine phosphate Conjunctivitis Conjunctival Diseases Histamine |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Histamine Antagonists Immune System Diseases Therapeutic Uses Physiological Effects of Drugs |
Histamine Agents Histamine H1 Antagonists Antipruritics Anti-Allergic Agents Dermatologic Agents Pharmacologic Actions |