Safety Study of Olopatadine Nasal Spray

Overview

The purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2008

Interventions

  • Drug: Olopatadine 0.6% nasal spray
    • 2 sprays each nostril twice daily
  • Drug: Placebo Nasal Spray
    • 2 sprays each nostril twice daily

Arms, Groups and Cohorts

  • Experimental: Olopatadine 0.6% Nasal Spray
    • 2 sprays each nostril twice daily
  • Placebo Comparator: Placebo Nasal Spray
    • 2 sprays each nostril twice daily

Clinical Trial Outcome Measures

Primary Measures

  • Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire
    • Time Frame: day 30
    • Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.

Secondary Measures

  • Average Number of Days of Rescue Medication Taken
    • Time Frame: Month 1 through Month 12

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older Exclusion Criteria:

  • Age 11 years and younger

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alcon Research
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Margaret Drake, Study Director, Alcon Research

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