Back to resultsSuccess of Transitioning Uncontrolled Glaucoma Patients From Prior Mono or Adjunctive Therapy to DuoTrav
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Travoprost 0.004%/timolol maleate 0.5% fixed combination ophthalmic solution (DuoTrav)
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Adults with primary open-angle glaucoma, ocular hypertension or pigment dispersion glaucoma.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Age related.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Mainz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DuoTrav
Arm Description
One drop in study eye(s) once daily in the evening (at 8:00 PM) for 12 weeks
Outcomes
Primary Outcome Measures
Change in intraocular pressure at 12 weeks from travoprost prior therapy (baseline)
Secondary Outcome Measures
Change in intraocular pressure at 12 weeks from other prior therapies (baseline)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00519753
Brief Title
Success of Transitioning Uncontrolled Glaucoma Patients From Prior Mono or Adjunctive Therapy to DuoTrav
Official Title
Safety and Efficacy of Switching to the Travoprost/Timolol Maleate Fixed Combination (DUOTRAV®) From Prior Mono or Two-Drug Therapy in Germany
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (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
The purpose of this study is to assess the safety and efficacy of transitioning uncontrolled glaucoma patients to DuoTrav from other mono or adjunctive therapies.
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
N/A
Enrollment
522 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DuoTrav
Arm Type
Experimental
Arm Description
One drop in study eye(s) once daily in the evening (at 8:00 PM) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Travoprost 0.004%/timolol maleate 0.5% fixed combination ophthalmic solution (DuoTrav)
Other Intervention Name(s)
DUOTRAV®
Intervention Description
One drop in study eye(s) once daily in the evening (at 8:00 PM) for 12 weeks
Primary Outcome Measure Information:
Title
Change in intraocular pressure at 12 weeks from travoprost prior therapy (baseline)
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in intraocular pressure at 12 weeks from other prior therapies (baseline)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults with primary open-angle glaucoma, ocular hypertension or pigment dispersion glaucoma.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Age related.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark C Jasek
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Mainz
City
Mainz
ZIP/Postal Code
DE-55101
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
20505839
Citation
Pfeiffer N, Scherzer ML, Maier H, Schoelzel S, Jasek MC, Stewart JA, Stewart WC. Safety and efficacy of changing to the travoprost/timolol maleate fixed combination (DuoTrav) from prior mono- or adjunctive therapy. Clin Ophthalmol. 2010 May 14;4:459-66. doi: 10.2147/opth.s10694.
Results Reference
result
Learn more about this trial
Success of Transitioning Uncontrolled Glaucoma Patients From Prior Mono or Adjunctive Therapy to DuoTrav
We'll reach out to this number within 24 hrs