Back to resultsTravatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Travoprost 0.004% Ophthalmic Solution (Travatan)
Timolol 0.5% Ophthalmic Solution (Timoptic)
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma
Eligibility Criteria
Inclusion Criteria:
- ≥18 years;
- IOP=16-30mmHg
OH or OAG with visual filed abnormality:
- ≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p <5% on the prepapillary diameter plot, one of which must have p <1%,
- Glaucoma Hemifield Test outside normal limits,
- Corrected Pattern Standard Deviation with p <5%
Exclusion Criteria:
- Previous damage of anterior chamber angle;
- ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) <1.0;
- contact lens wearer;
- severe central field loss;
- uncontrolled cardiovascular, hepatic or renal disease;
- any medication within past 1 month.
Sites / Locations
- Alcon Call Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Travoprost 0.004%
Timolol 0.5%
Arm Description
Travoprost 0.004%
Timolol 0.5%
Outcomes
Primary Outcome Measures
Mean Intraocular Pressure (IOP) at 9 AM
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Week 12 - Mean IOP At 4 PM
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Secondary Outcome Measures
Mean IOP Change From Baseline at 9 AM
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Mean IOP Change at 4 PM
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00763061
Brief Title
Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension
Official Title
A Twelve-Week, Double Masked, Parallel Group, Study of Travoprost 0.004% Compared to Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.
Detailed Description
To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.
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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Travoprost 0.004%
Arm Type
Experimental
Arm Description
Travoprost 0.004%
Arm Title
Timolol 0.5%
Arm Type
Active Comparator
Arm Description
Timolol 0.5%
Intervention Type
Drug
Intervention Name(s)
Travoprost 0.004% Ophthalmic Solution (Travatan)
Intervention Description
Travoprost at 9 AM + Placebo & 9 PM
Intervention Type
Drug
Intervention Name(s)
Timolol 0.5% Ophthalmic Solution (Timoptic)
Intervention Description
Timolol in each eye, twice daily at 9 AM & 9 PM
Primary Outcome Measure Information:
Title
Mean Intraocular Pressure (IOP) at 9 AM
Description
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Time Frame
At Week 12 - At the 9 AM time point for the patient's worse eye.
Title
Week 12 - Mean IOP At 4 PM
Description
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Time Frame
At the 4 PM time point for the patient's worse eye.
Secondary Outcome Measure Information:
Title
Mean IOP Change From Baseline at 9 AM
Description
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Time Frame
Baseline to Week 12 - at 9 AM
Title
Mean IOP Change at 4 PM
Description
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Time Frame
Baseline to Week 12 - at 4 PM
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥18 years;
IOP=16-30mmHg
OH or OAG with visual filed abnormality:
≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p <5% on the prepapillary diameter plot, one of which must have p <1%,
Glaucoma Hemifield Test outside normal limits,
Corrected Pattern Standard Deviation with p <5%
Exclusion Criteria:
Previous damage of anterior chamber angle;
ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) <1.0;
contact lens wearer;
severe central field loss;
uncontrolled cardiovascular, hepatic or renal disease;
any medication within past 1 month.
Facility Information:
Facility Name
Alcon Call Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
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Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension
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