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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
History of Changes
  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:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

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
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
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

ClinicalTrials.gov processed this record on May 16, 2013