Back to resultsA Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Open-angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AL-37807 Ophthalmic Suspension, 1.0%
Latanoprost, 0.005% (Xalatan)
AL-37807 Vehicle
Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma focused on measuring open, angle, glaucoma, ocular, hypertension
Eligibility Criteria
Inclusion Criteria: Diagnosed with open-angle glaucoma (with ot without pseudoexfoliation or pigment dispersion component) or ocular hypertension Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Under 18 Other protocol-defined exclusion criteria may apply.
Sites / Locations
- United States Investigative Sites in Texas and Other States
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Placebo Comparator
Experimental
Arm Label
AL-37807 Suspension
Xalatan
AL-37807 Vehicle
Timolol Maleate
Arm Description
Outcomes
Primary Outcome Measures
Mean intra-ocular pressure (IOP) change at Day 28 from baseline (Day 0)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00287521
Brief Title
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (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 determine whether a glaucoma therapy is safe and effective in treating 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
Open-angle Glaucoma, Ocular Hypertension
Keywords
open, angle, glaucoma, ocular, hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AL-37807 Suspension
Arm Type
Experimental
Arm Title
Xalatan
Arm Type
Active Comparator
Arm Title
AL-37807 Vehicle
Arm Type
Placebo Comparator
Arm Title
Timolol Maleate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AL-37807 Ophthalmic Suspension, 1.0%
Intervention Description
One drop in the study eye(s) once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Latanoprost, 0.005% (Xalatan)
Other Intervention Name(s)
XALATAN
Intervention Description
One drop in the study eye(s) once daily for 28 days
Intervention Type
Other
Intervention Name(s)
AL-37807 Vehicle
Intervention Description
One drop in the study eye(s) once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%
Intervention Description
One drop in the study eye(s) once daily for 28 days
Primary Outcome Measure Information:
Title
Mean intra-ocular pressure (IOP) change at Day 28 from baseline (Day 0)
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with open-angle glaucoma (with ot without pseudoexfoliation or pigment dispersion component) or ocular hypertension
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Under 18
Other protocol-defined exclusion criteria may apply.
Facility Information:
Facility Name
United States Investigative Sites in Texas and Other States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76180
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
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