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Mast-Cell Stabilizing Effects of Olopatadine

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ClinicalTrials.gov Identifier: NCT00389025
Recruitment Status : Completed
First Posted : October 17, 2006
Last Update Posted : November 22, 2016
Sponsor:
Information provided by:
Alcon Research

Tracking Information
First Submitted Date  ICMJE October 13, 2006
First Posted Date  ICMJE October 17, 2006
Last Update Posted Date November 22, 2016
Study Start Date  ICMJE October 2006
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2006)
Tear histamine
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2006)
Tear cytology, subject evaluation of ocular itching, investigators evaluation of ocular redness
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mast-Cell Stabilizing Effects of Olopatadine
Official Title  ICMJE Mast-Cell Stabilizing Effects of Olopatadine
Brief Summary To assess the effects of olopatadine of the release of mast cell histamine
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Allergic Conjunctivitis
Intervention  ICMJE Drug: Olopatadine (generic name)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2010)
24
Original Enrollment  ICMJE
 (submitted: October 16, 2006)
25
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Asymptomatic and not using any topical or systemic medication

Exclusion Criteria:

  • Age
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00389025
Other Study ID Numbers  ICMJE C-05-30
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Terry Wiernas Alcon Research
PRS Account Alcon Research
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP