Back to resultsA 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Glaucoma, Open-angle, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution
Latanoprost 0.005%/Timolol 0.005% ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-angle focused on measuring Glaucoma, POAG, OAG, OHT
Eligibility Criteria
Inclusion Criteria: - As specified in protocol Exclusion Criteria: - As specified in protocol
Sites / Locations
- European Facilitiies
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Travoprost/Timolol
Latanoprost/Timolol
Arm Description
1 drop in the affected eye(s) once daily in the morning for 12 months
1 drop in the affected eye(s) once daily in the morning for 12 months
Outcomes
Primary Outcome Measures
Mean Intraocular Pressure (IOP)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00311389
Brief Title
A 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official Title
A 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the intraocular pressure(IOP)-lowering efficacy of a combination IOP-lowering therapy 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
Glaucoma, Open-angle, Ocular Hypertension
Keywords
Glaucoma, POAG, OAG, OHT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
408 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Travoprost/Timolol
Arm Type
Experimental
Arm Description
1 drop in the affected eye(s) once daily in the morning for 12 months
Arm Title
Latanoprost/Timolol
Arm Type
Active Comparator
Arm Description
1 drop in the affected eye(s) once daily in the morning for 12 months
Intervention Type
Drug
Intervention Name(s)
Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution
Intervention Description
Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
Intervention Type
Drug
Intervention Name(s)
Latanoprost 0.005%/Timolol 0.005% ophthalmic solution
Intervention Description
Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
Primary Outcome Measure Information:
Title
Mean Intraocular Pressure (IOP)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- As specified in protocol
Exclusion Criteria:
- As specified in protocol
Facility Information:
Facility Name
European Facilitiies
City
Puurs
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
A 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension
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