A Phase II Study of AL-37807 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
Sponsored by
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Adult patients of either sex and any race with open-angle glaucoma or ocular hypertension; logMAR visual acuity not worse than 0.60; additionally clinically relevant ophthalmic or systemic conditions may be excluded
Exclusion Criteria:
- Under 18
Sites / Locations
- San Antonio Site
Outcomes
Primary Outcome Measures
Mean IOP change from baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00372931
Brief Title
A Phase II Study of AL-37807 to Treat Open-Angle Glaucoma or Ocular Hypertension
Official Title
A Phase II Study of AL-37807 to Treat Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
August 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 this study is to determine whether AL-37807 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AL-37807
Primary Outcome Measure Information:
Title
Mean IOP change from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients of either sex and any race with open-angle glaucoma or ocular hypertension; logMAR visual acuity not worse than 0.60; additionally clinically relevant ophthalmic or systemic conditions may be excluded
Exclusion Criteria:
Under 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Landry
Organizational Affiliation
Study Director
Official's Role
Study Director
Facility Information:
Facility Name
San Antonio Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study of AL-37807 to Treat Open-Angle Glaucoma or Ocular Hypertension
We'll reach out to this number within 24 hrs