Phase 3 Study to Evaluate IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertension C-02-41
Primary Purpose
Open-Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Alcon Investigational Agent
Sponsored by
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring open-angle, glaucoma, ocular, hypertension, POAG
Eligibility Criteria
Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; visual acuity of 20/80 to 20/400 or better (Snellen equivalent) or logMAR visual acuity not worse than 0.6. Clinically relevant ophthalmic or systemic conditions may be excluded.
Sites / Locations
- Clinical Trial Sites
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00047528
Brief Title
Phase 3 Study to Evaluate IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertension C-02-41
Official Title
Phase III Safety and Efficacy Study to Evaluate Combination IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertensive Patients (C-02-41).
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
November 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Ocular Hypertension
Keywords
open-angle, glaucoma, ocular, hypertension, POAG
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Alcon Investigational Agent
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; visual acuity of 20/80 to 20/400 or better (Snellen equivalent) or logMAR visual acuity not worse than 0.6. Clinically relevant ophthalmic or systemic conditions may be excluded.
Facility Information:
Facility Name
Clinical Trial Sites
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase 3 Study to Evaluate IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertension C-02-41
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