- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00287521
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
March 2, 2012 updated by: Alcon Research
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Fort Worth, Texas, United States, 76180
- United States Investigative Sites in Texas and Other States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Xalatan
|
One drop in the study eye(s) once daily for 28 days
Other Names:
|
Experimental: AL-37807 Suspension
|
One drop in the study eye(s) once daily for 28 days
|
Placebo Comparator: AL-37807 Vehicle
|
One drop in the study eye(s) once daily for 28 days
|
Experimental: Timolol Maleate
|
One drop in the study eye(s) once daily for 28 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean intra-ocular pressure (IOP) change at Day 28 from baseline (Day 0)
Time Frame: Day 28
|
Day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
February 1, 2006
Study Completion (Actual)
February 1, 2006
Study Registration Dates
First Submitted
February 3, 2006
First Submitted That Met QC Criteria
February 3, 2006
First Posted (Estimate)
February 7, 2006
Study Record Updates
Last Update Posted (Estimate)
March 5, 2012
Last Update Submitted That Met QC Criteria
March 2, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Glaucoma
- Glaucoma, Open-Angle
- Ocular Hypertension
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Pharmaceutical Solutions
- Ophthalmic Solutions
- Timolol
- Latanoprost
Other Study ID Numbers
- C-04-68
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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