Effect of Olopatadine on Allergic Tear Mediators

Allergic Conjunctivitis Clinical Trial

Official title:

Expression of Inflammatory Mediators in Allergic Conjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00609128
• Other study ID #: 1998-381
• Secondary ID: R01EY012526
• Status: Completed
• Phase: N/A
• Start date: September 2000
• Est. completion date: November 2009

Study information

• Verified date: August 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Skin test positive

• Able to put drops in eyes

• Able to have tears collected

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• olopatadine
olopatadine one drop in one eye for one week

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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