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

Alcon Research2,388 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

2,388

Conditions

Seasonal Allergic Rhinitis

Interventions

Olopatadine Hydrochloride Nasal Spray 0.6%DRUG

Olopatadine HCl 1 or 2 sprays per nostril twice daily

VehicleDRUG

Vehicle 1 or 2 sprays per nostril twice daily

Eligibility

Sex: ALLMin age: 6 YearsMax age: 11 Years

Medical Language ↔ Plain English

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

Locations (1)

Kenilworth/IL

Kenilworth, Illinois, United States

Outcomes

Primary Outcomes

Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)

Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days.

Time frame: Baseline through 2 weeks after randomization

Secondary Outcomes

Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)

Total Ocular Symptom Score comprised of scoring each of the following symptoms: itchy eyes and watery eyes. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 2 individual symptom scores were then added together for a total ocular symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 2 individual scores averaged across all days.

Time frame: Baseline through 2 weeks after randomization

Data from ClinicalTrials.gov

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