Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients

February 23, 2010 updated by: Alcon Research
A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2388

Phase

  • Phase 3

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
    • Illinois
      • Kenilworth, Illinois, United States, 60043
        • Kenilworth/IL

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

4 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female; minimum of 6 years of age and less than 12 years
  • 2 year history of seasonal allergic rhinitis

Exclusion Criteria:

  • Concurrent disease that might interfere with the investigation or evaluation of te study medication
  • Confirmed diagnosis of chronic rhinosinusitis within the last year
  • Asthma, with the exception of mild intermittent asthma
  • Anatomical nasal deformity
  • Nasal obstruction
  • Known non-responder to antihistamines for symptoms of Seasonal Allergic Rhinitis (SAR)
  • Chronic or intermittent use of of inhaled, oral, intramuscular intravenous corticosteroids ot topical steroids
  • Ocular disorder other that allergic conjunctivitis

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olopatadine 0.6% 1 Spray
Olopatadine HCl 0.6% 1 spray per nostril twice daily
Drug: Olopatadine Hydrochloride Nasal Spray 0.6%
Olopatadine HCl 1 or 2 sprays per nostril twice daily
Placebo Comparator: Vehicle 1 spray
Vehicle 1 spray per nostril twice daily
Drug: Vehicle
Vehicle 1 or 2 sprays per nostril twice daily
Experimental: Olopatadine 0.6% 2 sprays
Olopatadine HCl 0.6% 2 sprays per nostril twice daily
Drug: Olopatadine Hydrochloride Nasal Spray 0.6%
Olopatadine HCl 1 or 2 sprays per nostril twice daily
Placebo Comparator: Vehicle 2 sprays
Vehicle 2 sprays per nostril twice daily
Drug: Vehicle
Vehicle 1 or 2 sprays per nostril twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)
Time Frame: Baseline through 2 weeks after randomization

Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score.

The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days.
Baseline through 2 weeks after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)
Time Frame: Baseline through 2 weeks after randomization

Total Ocular Symptom Score comprised of scoring each of the following symptoms: itchy eyes and watery eyes. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 2 individual symptom scores were then added together for a total ocular symptom score.

The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 2 individual scores averaged across all days.
Baseline through 2 weeks after randomization

Collaborators and Investigators

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

Sponsor

Alcon Research

Investigators

  • Study Director: Ed Tumaian, ed.tumaian@alconlabs.com

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

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

September 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 19, 2007

First Posted (Estimate)

December 21, 2007

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 23, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-07-01

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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