Back to resultsExamining The Efficacy, Safety And Improved Tolerability Of Travoprost BAK Free Ophthalmic Solution (Travatan-Z) Compared To Prior Prostaglandin Therapy
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Travatan-Z
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Adults with a clinical diagnosis of ocular hypertension, or primary open-angle, pigment dispersion or exfoliation glaucoma in at least one eye (study eye)
Exclusion Criteria:
- Age
Sites / Locations
- Fridley
Outcomes
Primary Outcome Measures
Ocular Surface Disease Symptoms
Secondary Outcome Measures
Intraocular pressure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00444665
Brief Title
Examining The Efficacy, Safety And Improved Tolerability Of Travoprost BAK Free Ophthalmic Solution (Travatan-Z) Compared To Prior Prostaglandin Therapy
Official Title
Examining The Efficacy, Safety And Improved Tolerability Of Travoprost BAK Free Ophthalmic Solution (Travatan-Z) Compared To Prior Prostaglandin Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Examine the safety, tolerability and efficacy of travoprost benzalkonium chloride (BAK) free ophthalmic solution compared to either latanoprost or bimatoprost monotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
750 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Travatan-Z
Primary Outcome Measure Information:
Title
Ocular Surface Disease Symptoms
Secondary Outcome Measure Information:
Title
Intraocular pressure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults with a clinical diagnosis of ocular hypertension, or primary open-angle, pigment dispersion or exfoliation glaucoma in at least one eye (study eye)
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
Fridley
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19668762
Citation
Henry JC, Peace JH, Stewart JA, Stewart WC. Efficacy, safety, and improved tolerability of travoprost BAK-free ophthalmic solution compared with prior prostaglandin therapy. Clin Ophthalmol. 2008 Sep;2(3):613-21. doi: 10.2147/opth.s3881.
Results Reference
result
Learn more about this trial
Examining The Efficacy, Safety And Improved Tolerability Of Travoprost BAK Free Ophthalmic Solution (Travatan-Z) Compared To Prior Prostaglandin Therapy
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