Back to resultsMast-Cell Stabilizing Effects of Olopatadine
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Olopatadine (generic name)
Sponsored by
About this trial
This is an interventional prevention trial for Allergic Conjunctivitis focused on measuring Subject with clinical history of seasonal allergic conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Asymptomatic and not using any topical or systemic medication
Exclusion Criteria:
- Age
Sites / Locations
- Padova Site
Outcomes
Primary Outcome Measures
Tear histamine
Secondary Outcome Measures
Tear cytology, subject evaluation of ocular itching, investigators evaluation of ocular redness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00389025
Brief Title
Mast-Cell Stabilizing Effects of Olopatadine
Official Title
Mast-Cell Stabilizing Effects of Olopatadine
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
To assess the effects of olopatadine of the release of mast cell histamine
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
Subject with clinical history of seasonal allergic conjunctivitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Olopatadine (generic name)
Primary Outcome Measure Information:
Title
Tear histamine
Secondary Outcome Measure Information:
Title
Tear cytology, subject evaluation of ocular itching, investigators evaluation of ocular redness
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Asymptomatic and not using any topical or systemic medication
Exclusion Criteria:
Age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Wiernas
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Padova Site
City
Padova
Country
Italy
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrialsregister.eu/ctr-search/search?query=C-05-30
Description
Results on European Database
Learn more about this trial
Mast-Cell Stabilizing Effects of Olopatadine
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