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| Sponsor: | University of Wisconsin, Madison |
|---|---|
| Information provided by: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00609128 |
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 |
| 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
|
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 |
Inclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Neal P Barney, MD | University of Wisconsin, Madison |
More Information
| 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 |
|
tears conjunctival epithelial cells olopatadine impression cytology |
|
Conjunctivitis, Allergic Eye Diseases Conjunctivitis Conjunctival Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Olopatadine Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Allergic Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Central Nervous System Agents |
