Official Title: “A Phase III Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the CAC Model of Acute Allergic Conjunctivitis in Japanese Subjects”

The purpose of the study is to demonstrate safety and efficacy of Olopatadine 0.2% compared to its vehicle in Japanese subjects in the treatment of acute allergen-mediated conjunctivitis using the conjunctival allergen challenge (CAC) test.

Study Type: Interventional

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

Study Primary Completion Date: November 2009

Intervention(s) in this Clinical Trial

• Drug: Olopatadine 0.2% + Olopatadine 0.2% vehicle
  • Olopatadine 0.2% 1 drop in one eye and its vehicle in the contralateral eye 8 hours before CAC
• Drug: Olopatadine 0.1% + Olopatadine 0.1% Vehicle
  • Olopatadine 0.1% 1 drop in one eye and its vehicle in the contralateral eye 8 hours before CAC

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Olopatadine 0.2% + Olopatadine 0.2% Vehicle
  • Pataday + Pataday Vehicle
• Active Comparator: Olopatadine 0.1% + Olopatadine 0.1% Vehicle
  • Patanol + Patanol Vehicle

Primary Measures

• Ocular itching
  • Time Frame: 8 hours + 15 minutes post dose
    Safety Issue?: Yes
• Total redness
  • Time Frame: 8 hours + 15 minutes post-dose
    Safety Issue?: Yes

Secondary Measures

• Ocular itching
  • Time Frame: 4 hours and 8 hours post-dose
    Safety Issue?: Yes

Inclusion Criteria:

• Adults 18 years of age or older, either sex, Japanese ethnicity
• Seasonal Allergic Conjunctivitis--asymptomatic.

Exclusion Criteria:

• Manifest signs and symptoms of clinically active allergic conjunctivitis in either eye (> 1 for redness in any of the three vessels beds—conjuctival, episcleral, ciliary—or itching > 0) at the start of any visit.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Alcon Research

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00987272

Study ID Number: C-09-044

ClinicalTrials.gov Identifier: NCT00987272

Health Authority: United States: Food and Drug Administration