Back to resultsA Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Travoprost 40 mcg/ml + Timolol 5 mg/ml eye drops, solution (DuoTrav)
Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (Cosopt)
Timolol Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria: 18 or older. Diagnosis of glaucoma or ocular hypertension. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Under 18. Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Travoprost/Timolol
Dorzolamide/Timolol
Arm Description
Outcomes
Primary Outcome Measures
Mean Intra-Ocular Pressure (IOP)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00333125
Brief Title
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (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 compare the intraocular pressure (IOP)-lowering efficacy and safety of two combination products 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, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
319 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Travoprost/Timolol
Arm Type
Experimental
Arm Title
Dorzolamide/Timolol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Travoprost 40 mcg/ml + Timolol 5 mg/ml eye drops, solution (DuoTrav)
Other Intervention Name(s)
DuoTrav
Intervention Description
One drop in the study eye(s) once daily, 9 PM, for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (Cosopt)
Other Intervention Name(s)
Cosopt
Intervention Description
One drop in the study eye(s) twice daily for 6 weeks
Intervention Type
Other
Intervention Name(s)
Timolol Vehicle
Intervention Description
One drop in the study eye(s) once daily for 6 weeks
Primary Outcome Measure Information:
Title
Mean Intra-Ocular Pressure (IOP)
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 or older.
Diagnosis of glaucoma or ocular hypertension.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Under 18.
Other protocol-defined exclusion criteria may apply.
12. IPD Sharing Statement
Citations:
PubMed Identifier
2788589
Citation
Saeed M, Kadir S, Kaufman SL, Murray RR, Milligan F, Cotton PB. Bleeding following endoscopic sphincterotomy: angiographic management by transcatheter embolization. Gastrointest Endosc. 1989 Jul-Aug;35(4):300-3. doi: 10.1016/s0016-5107(89)72796-6.
Results Reference
result
Learn more about this trial
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
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