Seasonal Allergic Conjunctivitis
Conditions
Keywords
Allergic, Conjunctivitis, Ketotifen, Histamine
Brief summary
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.
Interventions
DRUGKetotifen
Sponsors
Alcon Research
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 3 years or older. * History of seasonal allergic conjunctivitis * Presence of bilateral ocular itching/conjunctival hyperaemia (redness) at baseline: 1. at least intensity degree 2 for itching, and 2. 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/
Countries
China
Outcome results
None listed