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

Last updated: July 28, 2014
Sponsor: Alcon Research
Overall Status: Completed

Phase

3

Condition

Allergy

Eye Disorders/infections

Allergies & Asthma

Treatment

N/A

Clinical Study ID

NCT00987272
C-09-044
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Japanese ethnicity.

  • Seasonal Allergic Conjunctivitis--asymptomatic.

  • Other protocol-defined inclusion criteria may apply.

Exclusion

Exclusion Criteria:

  • Manifest signs and symptoms of clinically active allergic conjunctivitis in either eye (>1 for redness in any of the 3 vessels beds - conjunctival, episcleral, ciliary - oritching >0) at the start of any visit.

  • Other protocol-defined exclusion criteria may apply.

Study Design

Total Participants: 267
Study Start date:
October 01, 2009
Estimated Completion Date:
November 30, 2009