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

July 28, 2014 updated by: Alcon Research

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 Overview

Study Type

Interventional

Enrollment (Actual)

267

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pataday+Pataday Vehicle
Olopatadine Hydrochloride Ophthalmic Solution 0.2%, 1 drop in 1 eye and Olopatadine 0.2% Vehicle in the contralateral eye
Other Names:
  • PATADAY®
Inactive ingredients used as placebo comparator
Active Comparator: Patanol+Patanol Vehicle
Olopatadine Hydrochloride Ophthalmic Solution, 0.1%, 1 drop in 1 eye and Olopatadine 0.1% Vehicle in the contralateral eye
Other Names:
  • PATANOL®
Inactive ingredients used as placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Ocular Itching Score
Time Frame: Day 0 of treatment: 3, 5, and 10 minutes post CAC
Day 0 of treatment: 3, 5, and 10 minutes post CAC

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Total Redness Score
Time Frame: Day 0 of treatment: 3, 10, 20 minutes post-CAC
Day 0 of treatment: 3, 10, 20 minutes post-CAC

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Pamela Smith, BS, Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

September 28, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (Estimate)

September 30, 2009

Study Record Updates

Last Update Posted (Estimate)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 28, 2014

Last Verified

July 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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