A Comparison of Olopatadine and Fluticasone in Patients With Allergic Conjunctivitis

April 2, 2008 updated by: Greiner, Jack V., OD DO PhD

A Comparison of Olopatadine Versus Fluticasone Nasal Spray in the Prevention of the Signs and Symptoms of Allergic Conjunctivitis

To compare the clinical efficacy of olopatadine and fluticasone in a 3-week single center, double-masked, randomized, placebo controlled parallel treatment conjunctival allergen challenge (CAC) study in patients with allergic conjunctivitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study will evaluate the efficacy of nasal anti-allergic therapy compared to ocular anti-allergic therapy in the prevention of ocular allergic symptoms.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • North Andover, Massachusetts, United States, 01845
        • Ophthalmic Research Associates, Inc

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:

  • At least 18 years of age & either sex, any race
  • Willing and able to follow all instructions and attend all study visits
  • Positive history of ocular allergies
  • Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge

Exclusion Criteria:

  • Have planned surgery during trial period
  • Female currently pregnant, planning a pregnancy, or lactating
  • Use of disallowed medications

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
Active Comparator: 1
Olopatadine
Drug: Olopatadine
Ophthalmic solution
Active Comparator: 2
Fluticasone
Drug: Fluticasone
Nasal spray
Placebo Comparator: 3
Placebo nasal spray
Drug: Saline
Nasal spray
Placebo Comparator: 4
Placebo Eyedrops
Drug: Artificial tears
Ophthalmic Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ocular itching
Time Frame: Minutes following CAC
Minutes following CAC

Secondary Outcome Measures

Outcome Measure
Time Frame
Ocular redness
Time Frame: Minutes following CAC
Minutes following CAC

Collaborators and Investigators

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

Sponsor

Greiner, Jack V., OD DO PhD

Investigators

  • Principal Investigator: Jack V Greiner, OD, DO, PhD, ORA, Inc.

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

February 1, 2008

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

April 2, 2008

First Submitted That Met QC Criteria

April 2, 2008

First Posted (Estimate)

April 9, 2008

Study Record Updates

Last Update Posted (Estimate)

April 9, 2008

Last Update Submitted That Met QC Criteria

April 2, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-003-04

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 Conjunctivitis, Allergic

Clinical Trials on Olopatadine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe