Back to resultsSafety and Efficacy of Changing to DuoTrav From Prior Therapy
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Travoprost 0.004%/Timolol 0.5% Fixed Combination eye drops solution (Duotrav®)
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
- Must have an IOP of between 19 to 35 millimeters mercury (mmHg) (at any time of the day) in at least one eye (which would be designated as the study eye).
- Must be willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
- Women who are pregnant or lactating.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator.
- Corneal dystrophies in either eye.
- Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
- Bronchial asthma or a history of bronchial asthma, bronchial hyper-reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
- History of severe allergic rhinitis.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DuoTrav
Arm Description
One drop in study eye(s) once daily for 8 weeks
Outcomes
Primary Outcome Measures
Change in Intraocular Pressure (IOP) at 8 weeks from prior therapy (baseline)
Goldmann applanation tonometry will be performed at the baseline visit and 8-week visit to record intraocular pressure (IOP). The difference between the two readings will be recorded as the change in IOP. IOP will be recorded in mmHg.
Secondary Outcome Measures
Percentage of subjects who reach target IOP (≤18 mmHg)
Goldmann applanation tonometry will be performed at the 8-week visit to record intraocular pressure. Percentage of patients who reach target IOP will be calculated by comparing patients with IOP ≤18 mmHg to the overall study population.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01230736
Brief Title
Safety and Efficacy of Changing to DuoTrav From Prior Therapy
Official Title
Assessing the Safety and Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients Uncontrolled on Bimatoprost 0.03%/Timolol 0.5% Therapy (Fixed or Unfixed)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (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 to assess the safety and efficacy of changing to DuoTrav® from prior bimatoprost 0.03%/timolol 0.5% (used concomitantly or in a fixed combination) pharmacotherapy in uncontrolled 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
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
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DuoTrav
Arm Type
Experimental
Arm Description
One drop in study eye(s) once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Travoprost 0.004%/Timolol 0.5% Fixed Combination eye drops solution (Duotrav®)
Other Intervention Name(s)
DuoTrav®
Intervention Description
One drop in study eye(s) once daily for 8 weeks
Primary Outcome Measure Information:
Title
Change in Intraocular Pressure (IOP) at 8 weeks from prior therapy (baseline)
Description
Goldmann applanation tonometry will be performed at the baseline visit and 8-week visit to record intraocular pressure (IOP). The difference between the two readings will be recorded as the change in IOP. IOP will be recorded in mmHg.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Percentage of subjects who reach target IOP (≤18 mmHg)
Description
Goldmann applanation tonometry will be performed at the 8-week visit to record intraocular pressure. Percentage of patients who reach target IOP will be calculated by comparing patients with IOP ≤18 mmHg to the overall study population.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
Must have an IOP of between 19 to 35 millimeters mercury (mmHg) (at any time of the day) in at least one eye (which would be designated as the study eye).
Must be willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
Women who are pregnant or lactating.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator.
Corneal dystrophies in either eye.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
Bronchial asthma or a history of bronchial asthma, bronchial hyper-reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
History of severe allergic rhinitis.
Other protocol-defined exclusion criteria may apply.
Facility Information:
City
Schweinfurt
ZIP/Postal Code
97421
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21773673
Citation
Scherzer ML, Liehneova I, Negrete FJ, Schnober D. Travoprost 0.004%/timolol 0.5% fixed combination in patients transitioning from fixed or unfixed bimatoprost 0.03%/timolol 0.5%. Adv Ther. 2011 Aug;28(8):661-70. doi: 10.1007/s12325-011-0043-z. Epub 2011 Jul 15.
Results Reference
result
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Safety and Efficacy of Changing to DuoTrav From Prior Therapy
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