Mast-Cell Stabilizing Effects of Olopatadine

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00389025
First received: October 13, 2006
Last updated: January 4, 2010
Last verified: January 2010
  Purpose

To assess the effects of olopatadine of the release of mast cell histamine


Condition Intervention Phase
Allergic Conjunctivitis
Drug: Olopatadine (generic name)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Mast-Cell Stabilizing Effects of Olopatadine

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Tear histamine

Secondary Outcome Measures:
  • Tear cytology, subject evaluation of ocular itching, investigators evaluation of ocular redness

Enrollment: 24
Study Start Date: October 2006
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Asymptomatic and not using any topical or systemic medication

Exclusion Criteria:

  • Age
  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: NCT00389025

Locations
Italy
Padova Site
Padova, Italy
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Terry Wiernas Alcon Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00389025     History of Changes
Other Study ID Numbers: C-05-30
Study First Received: October 13, 2006
Last Updated: January 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Subject with clinical history of seasonal allergic conjunctivitis

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

ClinicalTrials.gov processed this record on August 28, 2014