Allergic Eye Disease Tear Mediators - Full Text View

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00609128

Purpose

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	Intervention
Allergic Eye Disease	Drug: olopatadine

MedlinePlus related topics: Eye Diseases Pinkeye

Drug Information available for: Olopatadine Patanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Single Group Assignment
Official Title:	Expression of Inflammatory Mediators in Allergic Conjunctivitis

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

tear cytokine concentrations with and without treatment [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

conjunctival epithelial cell surface marker measured with and without treatment [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2000
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: olopatadine olopatadine one drop in one eye for two weeks

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609128

Locations

United States, Wisconsin
University of Wisconsin	Recruiting
Madison, Wisconsin, United States, 53705
Contact: Neal P Barney, MD 608-263-7681 npbarney@wisc.edu
Contact: Jim Stahl, PhD 608-263-6177 jlstahl@medicine.wisc.edu
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

Investigators

Principal Investigator:

Neal P Barney, MD

University of Wisconsin, Madison

More Information

Publications:

Cook EB, Stahl JL, Brooks AM, Graziano FM, Barney NP. Allergic tears promote upregulation of eosinophil adhesion to conjunctival epithelial cells in an ex vivo model: inhibition with olopatadine treatment. Invest Ophthalmol Vis Sci. 2006 Aug;47(8):3423-9.

Cook EB. Tear cytokines in acute and chronic ocular allergic inflammation. Curr Opin Allergy Clin Immunol. 2004 Oct;4(5):441-5. Review.

Responsible Party:	University of Wisconsin ( Neal Barney, MD )
Study ID Numbers:	1998-381, RO1 EY12526
Study First Received:	December 26, 2007
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00609128 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

tears
conjunctival epithelial cells
olopatadine
impression cytology

Study placed in the following topic categories:

Anti-Inflammatory Agents
Lacerations
Neurotransmitter Agents
Conjunctivitis, Allergic
Eye Diseases
Anti-Allergic Agents
Conjunctivitis
Olopatadine
Conjunctival Diseases
Histamine

Hypersensitivity
Histamine Antagonists
Analgesics, Non-Narcotic
Hypersensitivity, Immediate
Histamine H1 Antagonists
Histamine phosphate
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hypersensitivity
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Immune System Diseases
Conjunctivitis, Allergic
Eye Diseases
Histamine Agents

Conjunctivitis
Anti-Allergic Agents
Olopatadine
Conjunctival Diseases
Pharmacologic Actions
Histamine Antagonists
Analgesics, Non-Narcotic
Hypersensitivity, Immediate
Histamine H1 Antagonists
Peripheral Nervous System Agents
Histamine H1 Antagonists, Non-Sedating
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009