Effect of Olopatadine on Allergic Tear Mediators

August 23, 2018 updated by: University of Wisconsin, Madison

Expression of Inflammatory Mediators in Allergic Conjunctivitis

The purpose of the research is to determine which inflammatory substances are involved in causing allergic symptoms in the eye. Allergic conjunctivitis is a common problem with symptoms of temporary redness, itching, tearing, and swelling of the eyes. Substances released by cells in the affected tissues cause allergic reactions in the eye and elsewhere in the body.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ocular allergies are extremely common, affecting up to 80 million people in the USA. Our research question is:

Are there differences in inflammatory mediators and cell surface activation markers in patients undergoing seasonal allergic conjunctivitis compared to those with sight threatening disease such as Atopic Keratoconjunctivitis (AKC) and will the use of the anti-allergy eye drop, PATANOL® (olopatadine hydrochloride) affect these parameters?

Experimental Design:

Ocular surface cells (by impression cytology) and tears (via capillary tube) are collected from allergic, non-allergic, and AKC subjects undergoing an reaction induced either by seasonal allergen or topical allergen provocation (specificity and dose determined via skin testing). Ocular surface cells are evaluated for surface activation markers. Tears are evaluated for mediator content. Tears are also incubated with peripheral blood eosinophils and lymphocytes to see effects on adhesion to conjunctival epithelial cells.

Study Type

Interventional

Enrollment (Actual)

21

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
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Skin test positive
  • Able to put drops in eyes
  • Able to have tears collected

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olopatadine
one drop in one eye only two times per day at an interval of 6 to 8 hours for 1 week
Drug: olopatadine
olopatadine one drop in one eye for one week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Examined Whether the Incubation of Human Conjunctival Epithelial Cells With Tears Pooled From Allergic Subjects (One Eye With and Other Eye Without Olopatadine Treatment) Promotes Eosinophil Adhesion
Time Frame: 1 week for tear collection, tears stored at - 80 C until used

Outcome:

The collected tears (from 10 subjects)were pooled, incubated with primary conjunctival epithelial cells before eosinophil adhesion was measured via eosinophil peroxidase assay.

Eosinophils in eosinophils / square cm measured.
1 week for tear collection, tears stored at - 80 C until used

Collaborators and Investigators

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

Sponsor

University of Wisconsin, Madison

Collaborators

National Eye Institute (NEI)

Investigators

  • Principal Investigator: Neal P Barney, MD, University of Wisconsin, Madison

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, 2000

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

February 5, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Actual)

September 20, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1998-381
  • R01EY012526 (U.S. NIH Grant/Contract)

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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