Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients

Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients

A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis.

Inclusion Criteria:

• Male or female; minimum of 6 years of age and less than 12 years
• 2 year history of seasonal allergic rhinitis

Exclusion Criteria:

• Concurrent disease that might interfere with the investigation or evaluation of te study medication
• Confirmed diagnosis of chronic rhinosinusitis within the last year
• Asthma, with the exception of mild intermittent asthma
• Anatomical nasal deformity
• Nasal obstruction
• Known non-responder to antihistamines for symptoms of Seasonal Allergic Rhinitis (SAR)
• Chronic or intermittent use of of inhaled, oral, intramuscular intravenous corticosteroids ot topical steroids
• Ocular disorder other that allergic conjunctivitis