Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis
Safety and Efficacy Comparison Ketotifen Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
StatusCompleted No Results Posted
Indication/ConditionSeasonal Allergic Conjunctivitis
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.
Inclusion Criteria: Age 3 years or older. History of seasonal allergic conjunctivitis Presence of bilateral ocular itching/conjunctival hyperaemia (redness) at baseline: at least intensity degree 2 for itching, and at least intensity degree 4 for composite score of itching and conjunctival hyperaemia Exclusion Criteria: Other systemic/ophthalmic conditions Presence of any form of allergic conjunctivitis other than seasonal allergic conjunctivitis (e.g. perennial allergic conjunctivitis, vernal keratoconjunctivitis, atopic keratoconjunctivitis, giant papillary conjunctivitis). Active bacterial or viral conjunctivitis or history of ocular herpes. Presence or history of severe dry eye. Previous treatments Any systemic or ocular corticosteroids within two (2) weeks prior to randomization. Any systemic or ocular mast cell stabilizers within two (2) weeks prior to randomization. Any other ophthalmic medication within three (3) days prior to randomization. Other protocol-defined inclusion/exclusion criteria may apply