NCT00609128

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
8.9 years until next milestone

Results Posted

Study results publicly available

September 20, 2018

Completed
Last Updated

September 20, 2018

Status Verified

August 1, 2018

Enrollment Period

9.2 years

First QC Date

December 26, 2007

Results QC Date

June 22, 2012

Last Update Submit

August 23, 2018

Conditions

Keywords

tearsconjunctival epithelial cellsolopatadineeosinophils

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Olopatadine

EXPERIMENTAL

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

Drug: olopatadine

Interventions

olopatadine one drop in one eye for one week

Olopatadine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (2)

  • 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.

    PMID: 15349046BACKGROUND
  • 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.

MeSH Terms

Conditions

Conjunctivitis, AllergicLacerations

Interventions

Olopatadine Hydrochloride

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

DibenzoxepinsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Jim Stahl, PhD
Organization
University of Wisconsin-Madison

Study Officials

  • Neal P Barney, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

February 6, 2008

Study Start

September 1, 2000

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

September 20, 2018

Results First Posted

September 20, 2018

Record last verified: 2018-08

Locations