Back to resultsDose Response Study of AL-37807 Ophthalmic Solution in Patients With 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
Xalatan
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:
- Open-angle glaucoma
- ocular hypertension
Exclusion Criteria:
- VA worse than 0.60
Sites / Locations
- Atlanta
Outcomes
Primary Outcome Measures
Mean IP Change from Baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00465621
Brief Title
Dose Response Study of AL-37807 Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official Title
Dose Response Study of AL-37807 Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
The purpose of thie study is to compare the safety and IOP-lowering efficacy of AL-37807 Ophthalmic Solution 0.05%, 0.1% and 0.2% dosed QD AM to Xalatan dosed QD PM and Vehicle 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
Open-Angle Glaucoma, Ocular Hypertension
Keywords
Open-angle glaucoma, ocular hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Xalatan
Primary Outcome Measure Information:
Title
Mean IP Change from Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Open-angle glaucoma
ocular hypertension
Exclusion Criteria:
- VA worse than 0.60
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Landry
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dose Response Study of AL-37807 Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
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