Olopatadine Eye Drops and Allergy Skin Testing

June 12, 2017 updated by: John Michael Fahrenholz, Vanderbilt University Medical Center

Effect of Olopatadine Hydrochloride 0.2% Ophthalmic Solution on Epicutaneous Skin Prick Testing With Histamine and Saline

Use of olopatadine ophthalmic solution (eye drops) will decrease allergy skin test reactivity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

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
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt Asthma, Sinus and Allergy Program Research

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 to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged 18 to 75 years
  • Healthy volunteers (no major illnesses or active symptoms)

Exclusion Criteria:

  • Known allergy or hypersensitivity to the drugs or components
  • Pregnant or nursing women
  • Women wishing to become pregnant during the study's duration
  • Use of topical or oral medications with antihistaminic activity for 14 days proceeding randomization
  • Dermatographism as evidenced on skin testing on visit 1
  • Chronic urticaria active within the past 6 months
  • Severe hypertension
  • Psychiatric diagnoses which could potentially affect medication compliance, such as schizophrenia or delusional disorders, as determined by the investigator obtaining informed consent and based on the subject's past medical history
  • Inability to provide informed consent

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: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: olopatadine then placebo
participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
Drug: olopatadine
olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day
Drug: placebo
placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day
ACTIVE_COMPARATOR: placebo then olopatadine
participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
Drug: olopatadine
olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day
Drug: placebo
placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
Time Frame: at baseline and at return visit (between study day 7-10)
at baseline and at return visit (between study day 7-10)
The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
Time Frame: at baseline and at return visit (between study day 7-10)
at baseline and at return visit (between study day 7-10)

Collaborators and Investigators

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

Sponsor

Vanderbilt University Medical Center

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

January 1, 2008

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

October 17, 2008

First Submitted That Met QC Criteria

October 17, 2008

First Posted (ESTIMATE)

October 20, 2008

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2017

Last Update Submitted That Met QC Criteria

June 12, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 071260

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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