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

Alcon

Status and phase: Completed; Phase 3

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Vehicle; Drug: Olopatadine Hydrochloride Nasal Spray 0.6%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00578929

C-07-01

Details and patient eligibility

About

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.

Enrollment: 2,388 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,388 participants in 4 patient groups, including a placebo group

Olopatadine 0.6% 1 Spray

Experimental group

Description:

Olopatadine HCl 0.6% 1 spray per nostril twice daily

Treatment:

Drug: Olopatadine Hydrochloride Nasal Spray 0.6%

Vehicle 1 spray

Placebo Comparator group

Description:

Vehicle 1 spray per nostril twice daily

Treatment:

Drug: Vehicle

Olopatadine 0.6% 2 sprays

Experimental group

Description:

Olopatadine HCl 0.6% 2 sprays per nostril twice daily

Treatment:

Drug: Olopatadine Hydrochloride Nasal Spray 0.6%

Vehicle 2 sprays

Placebo Comparator group

Description:

Vehicle 2 sprays per nostril twice daily

Treatment:

Drug: Vehicle