Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis

August 10, 2017 updated by: Alcon Research

A Comparative Study of Olopatadine 0.2% Versus Vehicle in Patients With Seasonal Allergic Conjunctivitis or Rhinoconjunctivitis

The purpose of this study is to demonstrate that Olopatadine 0.2% is superior to vehicle in the treatment of the signs and symptoms associated with allergic conjunctivitis or rhinoconjunctivitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

287

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

10 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of seasonal allergic conjunctivitis or rhinoconjunctivitis, a positive grass antigen challenge reaction (skin test), and a positive response to grass in the Conjunctival Allergen Challenge (CAC) model

Exclusion Criteria:

  • Under 10 years of age

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Olopatadine Hydrochloride 0.2%
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop in each eye, once-daily in the morning for 6 weeks
Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
PLACEBO_COMPARATOR: Vehicle
Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop in each eye, once-daily in the morning for 6 weeks
Drug: Olopatadine Hydrochloride Ophthalmic Solution Vehicle
Inactive ingredients used as a placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Daily ocular itching and redness scores
Time Frame: Up to Day 14
Up to Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with daily ocular itching and redness scores of 0
Time Frame: Up to Day 14
Up to Day 14

Collaborators and Investigators

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

Sponsor

Alcon Research

Investigators

  • Study Director: Alcon, A Novartis Company, Alcon, a Novartis Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • https://www.ncbi.nlm.nih.gov/pubmed/23379201

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 (ACTUAL)

April 18, 2006

Primary Completion (ACTUAL)

July 27, 2006

Study Completion (ACTUAL)

July 27, 2006

Study Registration Dates

First Submitted

May 30, 2006

First Submitted That Met QC Criteria

May 30, 2006

First Posted (ESTIMATE)

May 31, 2006

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2017

Last Update Submitted That Met QC Criteria

August 10, 2017

Last Verified

June 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-04-60

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.

Clinical Trials on Allergic Conjunctivitis

Clinical Trials on Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe