Allergic Eye Disease Tear Mediators

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00609128
Recruitment Status : Unknown
Verified October 2008 by University of Wisconsin, Madison.
Recruitment status was:  Recruiting
First Posted : February 6, 2008
Last Update Posted : November 3, 2008
Information provided by:
University of Wisconsin, Madison

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Allergic Eye Disease Drug: olopatadine Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Expression of Inflammatory Mediators in Allergic Conjunctivitis
Study Start Date : September 2000
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: olopatadine
olopatadine one drop in one eye for two weeks

Primary Outcome Measures :
  1. tear cytokine concentrations with and without treatment [ Time Frame: 1-3 months ]

Secondary Outcome Measures :
  1. conjunctival epithelial cell surface marker measured with and without treatment [ Time Frame: 1-3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00609128

United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Contact: Neal P Barney, MD    608-263-7681   
Contact: Jim Stahl, PhD    608-263-6177   
Principal Investigator: Neal P Barney, MD         
Sub-Investigator: Frank M Graziano, MD PhD         
Sub-Investigator: Ellen B Cook, PhD         
Sub-Investigator: Jim Stahl, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Neal P Barney, MD University of Wisconsin, Madison

Publications of Results:
Other Publications:
Responsible Party: Neal Barney, MD, University of Wisconsin Identifier: NCT00609128     History of Changes
Other Study ID Numbers: 1998-381
R01EY012526 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: November 3, 2008
Last Verified: October 2008

Keywords provided by University of Wisconsin, Madison:
conjunctival epithelial cells
impression cytology

Additional relevant MeSH terms:
Eye Diseases
Olopatadine Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action