Back to resultsStudy of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Open-angle Glaucoma, Ocular Hypertension
Status
Terminated
Phase
Phase 4
Locations
Portugal
Study Type
Interventional
Intervention
Travatan
Cosopt
Placebo (Timolol Vehicle)
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Patient with open-angle glaucoma or ocular hypertension
Exclusion Criteria:
- By Age
Sites / Locations
- Coimbra
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Travatan
Cosopt
Arm Description
Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)
Outcomes
Primary Outcome Measures
Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment
IOP measured at week 6 minus IOP measured at baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00471068
Brief Title
Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension
Official Title
Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Terminated
Why Stopped
Question raised by Ethics Committee
Study Start Date
March 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
undefined (undefined)
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
To compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Travatan
Arm Type
Experimental
Arm Description
Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
Arm Title
Cosopt
Arm Type
Active Comparator
Arm Description
treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)
Intervention Type
Drug
Intervention Name(s)
Travatan
Intervention Description
Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
Intervention Type
Drug
Intervention Name(s)
Cosopt
Intervention Description
treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)
Intervention Type
Drug
Intervention Name(s)
Placebo (Timolol Vehicle)
Intervention Description
Travatan group: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
Primary Outcome Measure Information:
Title
Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment
Description
IOP measured at week 6 minus IOP measured at baseline
Time Frame
At week 0 and week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with open-angle glaucoma or ocular hypertension
Exclusion Criteria:
By Age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Grau
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Coimbra
City
Coimbra
ZIP/Postal Code
3000354
Country
Portugal
12. IPD Sharing Statement
Learn more about this trial
Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension
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