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...
Date First Received: December 26, 2007
Last Updated: October 30, 2008
Verified by: University of Wisconsin, Madison, October 2008
Clinical Trial Phase: N/A | Start Date: September 2000
Overall Status: Recruiting
Estimated Enrollment: 40
Brief Summary
Official Title: “Expression of Inflammatory Mediators in Allergic Conjunctivitis”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Basic Science, Open Label, Single Group Assignment
Study Primary Completion Date: September 2010
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: olopatadine
- olopatadine one drop in one eye for two weeks
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
Outcome Measures for this Clinical Trial
Primary Measures
- tear cytokine concentrations with and without treatment
- Time Frame: 1-3 months
Safety Issue?: No
- Time Frame: 1-3 months
Secondary Measures
- conjunctival epithelial cell surface marker measured with and without treatment
- Time Frame: 1-3 months
Safety Issue?: No
- Time Frame: 1-3 months
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Skin test positive
- Able to put drops in eyes
- Able to have tears collected
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: University of Wisconsin, Madison
Overall Clinical Trial Officials and Contacts
Neal P Barney, MD Principal Investigator University of Wisconsin, Madison
Related Publications
References
Cook EB. Tear cytokines in acute and chronic ocular allergic inflammation. Curr Opin Allergy Clin Immunol. 2004 Oct;4(5):441-5. Review.
Citations Reporting Results
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.
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00609128
Study ID Number: 1998-381
ClinicalTrials.gov Identifier: NCT00609128
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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