Official Title: “Safety Study of Olpatadine Nasal Spray”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

• Drug: Olopatadine hydrochloride
  • Nasal spray

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 2
• Placebo Comparator: 1

Primary Measures

• mean response at day 30 to the patient-rated relief assessment questionnaire
  • Time Frame: day 30
    Safety Issue?: No

Secondary Measures

• average number of days to rescue mediciation was used and the mean response (average of visits 2 through the last scheduled or unscheduled visit) to the patient-rated relief assessment questionnaire.
  • Time Frame: from baseline
    Safety Issue?: No

Inclusion Criteria:

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

Exclusion Criteria:

• Age

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Alcon Research

Overall Clinical Trial Officials and Contacts

Margaret Drake Study Director Alcon Research  

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00578331

Study ID Number: C-05-69

ClinicalTrials.gov Identifier: NCT00578331

Health Authority: United States: Food and Drug Administration