Back to resultsShort Term Comparative Study of Xalatan With Benzalkonium Chloride vs. Travatan Z Without Benzalkonium Chloride in Healthy Volunteers
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Travatan® Z
Xalatan®
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Adults with primary open-angle glaucoma, ocular hypertension or pigment dispersion glaucoma
Exclusion Criteria:
- Age
Sites / Locations
- Orlando
Outcomes
Primary Outcome Measures
Tear Break Up Time
Secondary Outcome Measures
Safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00468988
Brief Title
Short Term Comparative Study of Xalatan With Benzalkonium Chloride vs. Travatan Z Without Benzalkonium Chloride in Healthy Volunteers
Official Title
Short Term Comparative Study of Xalatan With Benzalkonium Chloride vs. Travatan Z Without Benzalkonium Chloride in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
Compare the effect of Xalatan with benzalkonium chloride on the ocular surface to those effects observed with Travatan Z without benzalkonium chloride after a single dose
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Travatan® Z
Intervention Type
Drug
Intervention Name(s)
Xalatan®
Primary Outcome Measure Information:
Title
Tear Break Up Time
Time Frame
Day
Secondary Outcome Measure Information:
Title
Safety
Time Frame
Onset
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults with primary open-angle glaucoma, ocular hypertension or pigment dispersion glaucoma
Exclusion Criteria:
Age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Jasek, PhD
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Short Term Comparative Study of Xalatan With Benzalkonium Chloride vs. Travatan Z Without Benzalkonium Chloride in Healthy Volunteers
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