Allergic Eye Disease Tear Mediators

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00609128
First received: December 26, 2007
Last updated: October 30, 2008
Last verified: October 2008
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Expression of Inflammatory Mediators in Allergic Conjunctivitis

Resource links provided by NLM:


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
Experimental: 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by University of Wisconsin, Madison:
tears
conjunctival epithelial cells
olopatadine
impression cytology

Additional relevant MeSH terms:
Eye Diseases
Olopatadine
Analgesics
Analgesics, Non-Narcotic
Anti-Allergic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014