A 6-Week Safety and Efficacy Study of Travatan Compared to Xalcom in Subjects With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT)
Primary Purpose
Glaucoma, Open-Angle, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Travoprost (0.004%)
Latanoprost (0.005%)/Timolol (0.5%)
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring Glaucoma, POAG, OAG, OHT
Eligibility Criteria
Patients of any race and either sex with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or ocular hypertension.
Sites / Locations
- Europe
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00051155
Brief Title
A 6-Week Safety and Efficacy Study of Travatan Compared to Xalcom in Subjects With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT)
Official Title
A 6-Week Safety and Efficacy Study of TRAVATAN Compared to XALCOM in Subjects With Open-Angle Glaucoma or Ocular Hypertension.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
To compare the safety and IOP-lowering efficacy of TRAVATAN and XALCOM in subjects with open-angle glaucoma or ocular hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Ocular Hypertension
Keywords
Glaucoma, POAG, OAG, OHT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Travoprost (0.004%)
Intervention Type
Drug
Intervention Name(s)
Latanoprost (0.005%)/Timolol (0.5%)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients of any race and either sex with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or ocular hypertension.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon Investigators
Organizational Affiliation
Alcon Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Europe
City
Fort Worth
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A 6-Week Safety and Efficacy Study of Travatan Compared to Xalcom in Subjects With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT)
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