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

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.
 
ClinicalTrials.gov Identifier: NCT00287521
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : March 5, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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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.

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : November 2005
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
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


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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00287521    
Other Study ID Numbers: C-04-68
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012
Keywords provided by Alcon Research:
open
angle
glaucoma
ocular
hypertension
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Latanoprost
 Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents