Skip to main content
OpenTrials
Completed

NCT Number: NCT00987272

Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Japanese ethnicity.
  • Seasonal Allergic Conjunctivitis--asymptomatic.
  • Other protocol-defined inclusion criteria may apply.

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 - or itching >0) at the start of any visit.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Drug

Other names: PATADAY®

Olopatadine hydrochloride ophthalmic solution, 0.1%

Drug

Other names: PATANOL®

Olopatadine 0.2% Vehicle

Drug

Inactive ingredients used as placebo comparator

Olopatadine 0.1% Vehicle

Drug

Inactive ingredients used as placebo comparator

Primary outcomes

  1. Mean Ocular Itching Score

    Time frame: Day 0 of treatment: 3, 5, and 10 minutes post CAC

Secondary outcomes

  1. Mean Total Redness Score

    Time frame: Day 0 of treatment: 3, 10, 20 minutes post-CAC

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 30, 2009
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.