Back to resultsA Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Open-angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Travoprost, Investigational
Travoprost (TRAVATAN)
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma focused on measuring open-angle, glaucoma, ocular, hypertension
Eligibility Criteria
Inclusion Criteria: Adult patients of either sex of any race diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Under age 18. Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Travatan, Investigational
Travatan
Arm Description
Outcomes
Primary Outcome Measures
Mean IOP
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00293761
Brief Title
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to determine whether a glaucoma therapy is safe and effective in treating patients 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
Open-angle Glaucoma, Ocular Hypertension
Keywords
open-angle, glaucoma, ocular, hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Travatan, Investigational
Arm Type
Experimental
Arm Title
Travatan
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Travoprost, Investigational
Intervention Description
One drop in study eye once daily for 13 days
Intervention Type
Drug
Intervention Name(s)
Travoprost (TRAVATAN)
Other Intervention Name(s)
TRAVATAN
Intervention Description
One drop in study eye once daily for 13 days
Primary Outcome Measure Information:
Title
Mean IOP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients of either sex of any race diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Under age 18.
Other protocol-defined exclusion criteria may apply.
12. IPD Sharing Statement
Citations:
PubMed Identifier
18414108
Citation
Gross RL, Peace JH, Smith SE, Walters TR, Dubiner HB, Weiss MJ, Ochsner KI. Duration of IOP reduction with travoprost BAK-free solution. J Glaucoma. 2008 Apr-May;17(3):217-22. doi: 10.1097/IJG.0b013e31815a3472.
Results Reference
result
Learn more about this trial
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
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