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OpenTrials
Completed

NCT Number: NCT00578929

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.

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kenilworth/IL

Kenilworth, Illinois, 60043, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olopatadine Hydrochloride Nasal Spray 0.6%

Drug

Olopatadine HCl 1 or 2 sprays per nostril twice daily

Vehicle

Drug

Vehicle 1 or 2 sprays per nostril twice daily

Primary outcomes

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

    Time frame: Baseline through 2 weeks after randomization

    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.

Secondary outcomes

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

    Time frame: Baseline through 2 weeks after randomization

    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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
First posted
Dec 21, 2007
Registry last updated
Mar 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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