Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese Subjects

Verified by: Alcon Research, January 2012
First Received: September 28, 2009 | Last Updated: January 11, 2012 | Phase: Phase 3 | Start Date: September 2009
Overall Status: Completed | Estimated Enrollment: 267
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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...

Brief Summary

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: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • 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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Alcon Research Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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