We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00287521
First Posted: February 7, 2006
Last Update Posted: March 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
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.

Condition Intervention Phase
Open-angle Glaucoma Ocular Hypertension Drug: AL-37807 Ophthalmic Suspension, 1.0% Drug: Latanoprost, 0.005% (Xalatan) Other: AL-37807 Vehicle Drug: Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean intra-ocular pressure (IOP) change at Day 28 from baseline (Day 0) [ Time Frame: Day 28 ]

Enrollment: 87
Study Start Date: November 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-37807 Suspension Drug: AL-37807 Ophthalmic Suspension, 1.0%
One drop in the study eye(s) once daily for 28 days
Active Comparator: Xalatan Drug: Latanoprost, 0.005% (Xalatan)
One drop in the study eye(s) once daily for 28 days
Other Name: XALATAN
Placebo Comparator: AL-37807 Vehicle Other: AL-37807 Vehicle
One drop in the study eye(s) once daily for 28 days
Experimental: Timolol Maleate Drug: Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%
One drop in the study eye(s) once daily for 28 days

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287521


Locations
United States, Texas
United States Investigative Sites in Texas and Other States
Fort Worth, Texas, United States, 76180
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00287521     History of Changes
Other Study ID Numbers: C-04-68
First Submitted: February 3, 2006
First Posted: February 7, 2006
Last Update Posted: March 5, 2012
Last Verified: March 2012

Keywords provided by Alcon Research:
open
angle
glaucoma
ocular
hypertension

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Latanoprost
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors