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Effect of Olopatadine on Allergic Tear Mediators

Primary Purpose

Allergic Conjunctivitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

olopatadine

About this trial

This is an interventional basic science trial for Allergic Conjunctivitis focused on measuring tears, conjunctival epithelial cells, olopatadine, eosinophils

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

University of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Olopatadine

Arm Description

one drop in one eye only two times per day at an interval of 6 to 8 hours for 1 week

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00609128

First Posted

December 26, 2007

Last Updated

August 23, 2018

Sponsor

University of Wisconsin, Madison

Collaborators

National Eye Institute (NEI)

1. Study Identification

Unique Protocol Identification Number

NCT00609128

Brief Title

Effect of Olopatadine on Allergic Tear Mediators

Official Title

Expression of Inflammatory Mediators in Allergic Conjunctivitis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

September 2000 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

Collaborators

National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Conjunctivitis

Keywords

tears, conjunctival epithelial cells, olopatadine, eosinophils

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Olopatadine

Arm Type

Experimental

Arm Description

one drop in one eye only two times per day at an interval of 6 to 8 hours for 1 week

Intervention Type

Drug

Intervention Name(s)

olopatadine

Intervention Description

olopatadine one drop in one eye for one week

Primary Outcome Measure Information:

Title

Description

Time Frame

1 week for tear collection, tears stored at - 80 C until used

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neal P Barney, MD

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Wisconsin

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15349046

Citation

Cook EB. Tear cytokines in acute and chronic ocular allergic inflammation. Curr Opin Allergy Clin Immunol. 2004 Oct;4(5):441-5. doi: 10.1097/00130832-200410000-00018.

Results Reference

background

PubMed Identifier

16877412

Citation

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. doi: 10.1167/iovs.06-0088.

Results Reference

result

Learn more about this trial

Effect of Olopatadine on Allergic Tear Mediators

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