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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Olopatadine Hydrochloride

Criteria

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