The purpose of this study is to demonstrate that Olopatadine 0.2% is superior to vehicle in the treatment of the signs and symptoms associated with allergic conjunctivitis or rhinoconjunctivitis...
Date First Received: May 30, 2006
Last Updated: June 11, 2008
Verified by: Alcon Research, June 2008
Clinical Trial Phase: Phase 3 | Start Date: August 2006
Overall Status: Completed
Estimated Enrollment: 250
Brief Summary
Official Title: “A Comparative Study of Olopatadine 0.2% Versus Vehicle in Patients With Seasonal Allergic Conjunctivitis or Rhinoconjunctivitis”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to demonstrate that Olopatadine 0.2% is superior to vehicle in the treatment of the signs and symptoms associated with allergic conjunctivitis or rhinoconjunctivitis.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: August 2007
Intervention(s) in this Clinical Trial
- Drug: olopatadine 0.2%
Outcome Measures for this Clinical Trial
Primary Measures
- Daily signs and symptoms scores during the 14 days of peak pollen
Secondary Measures
- Patients with daily signs and symptoms scores of zero during the 14 days of peak pollen
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- History of seasonal allergic conjunctivitis or rhinoconjunctivitis, a positive grass antigen challenge reaction (skin test), and a positive response to grass in the Conjunctival Allergen Challenge (CAC) model
Exclusion Criteria:
- Under 10 years of age
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 10 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Alcon Research
Overall Clinical Trial Officials and Contacts
Stella Robertson Study Director Study Director
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00331500
Study ID Number: C-04-60
ClinicalTrials.gov Identifier: NCT00331500
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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